The American Journal of Orthopedics

ABSTRACT

Tranexamic acid (TXA) is an effective agent used for reducing perioperative blood loss and decreasing the potential for postoperative hemarthrosis. We hypothesized that patients who had received intraoperative TXA during total ankle arthroplasty (TAA) would have a reduction in postoperative drain output, thereby resulting in a reduced risk of postoperative hemarthrosis and lower wound complication rates.

A retrospective review was conducted on 50 consecutive patients, 25 receiving TXA (TXA-TAA) and 25 not receiving TXA (No TXA-TAA), who underwent an uncemented TAA between September 2011 and December 2015. Demographic characteristics, drain output, preoperative and postoperative hemoglobin levels, operative and postoperative course, and minor and major wound complications of the patients were reviewed.

Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P < .0001). The overall wound complication rate in the No TXA-TAA group was higher (20%, 5/25) than that in the TXA-TAA group (8%, 2/25) (P = .114). The mean change in preoperative to postoperative hemoglobin level was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively, P = .01).

TXA is an effective hemostatic agent when used during TAA. TXA reduces perioperative blood loss, hemarthrosis, and the risk of wound complications.

Continue to: End-stage ankle arthritis...

End-stage ankle arthritis is a disabling condition that may lead to poor quality of life and difficulties with activities of daily living.¹ The associated mental and physical disability has been demonstrated to be as severe as in end-stage hip arthrosis.² Operative treatment for symptomatic end-stage ankle arthritis includes arthrodesis or total ankle arthroplasty (TAA) in those refractory to nonoperative treatment.³ Newer generation implants have made TAA a more attractive option for both the surgeon and the patient.

Over the past decade, the utility of TAA has increased and attention has turned toward the management of perioperative factors that would maximize patient satisfaction and decrease the length of stay and complication rates, as well as hospital costs.⁴ Comprehensive literature on total knee arthroplasty (TKA) and total hip arthroplasty (THA) has demonstrated that the management of perioperative blood loss, specifically postoperative hemarthrosis, is a modifiable factor affecting patient recovery, complication rates, and hospital costs.^5-8 Drain output has been used as a direct measure of intra-articular blood accumulation.⁹ Decreased drain output implies decreased hemarthrosis, which could potentially alleviate the pressure on the wound and decrease wound complications.

One of the major strategies that has been recognized for reducing blood loss and decreasing the potential for postoperative hemarthrosis is the use of intravenous (IV) or topical tranexamic acid (TXA).^10,11 TXA is a synthetic antifibrinolytic medication that has been extensively used throughout the medical field since the 1960s to help control the bleeding cascade. This medication stabilizes clot formation without inducing a pro-coaguable state.¹² Intraoperative administration of TXA has been shown to reduce drain output and decrease transfusion requirements after TKA and THA without an associated increase in patient morbidity and mortality.^6,11,13-15

Currently, there is a lack of studies evaluating the utility of TXA during TAA. We hypothesize that compared with patients who had not received TXA, those who had received intraoperative TXA during TAA would have a reduction in postoperative drain output and therefore decreased hemarthrosis, lower wound complication rate, and a diminished change in preoperative to postoperative hemoglobin levels, reflecting a reduction in perioperative blood loss.

MATERIALS AND METHODS

This study was approved by the Institutional Review Board at the University at Buffalo, State University of New York. A retrospective chart review was conducted on 50 consecutive patients who underwent an uncemented TAA with the Salto Talaris total ankle prosthesis (Tornier, Inc) between September 2011 and December 2015. All surgeries were performed at 1 institution by a single fellowship surgeon trained in foot and ankle surgery through the anterior approach where a midline incision was made over the ankle. The interval between the tibialis anterior tendon and the extensor hallucis longus tendon was used. We had incorporated intraoperative TXA into the TAA surgical protocol at our institution in January 2014. We evaluated the first 25 consecutive patients who underwent TAA after TXA use began (TXA-TAA) and another 25 consecutive patients who underwent TAA before the routine use of TXA (No TXA-TAA). Inclusion criteria were patients who presented with pain, decreased function, and radiographic parameters of end-stage tibiotalar arthritis due to degenerative arthritis, rheumatoid arthritis, or posttraumatic arthritis who subsequently underwent a TAA. Exclusion criteria were patients with a contraindication for IV TXA use, a preexisting coagulopathy, or where drain output was not recorded. Contraindications for IV TXA use included patients with impaired renal clearance, recent cardiac surgery, myocardial infarction, ischemic stroke, or venous thromboembolism (VTE). Seven patients were ultimately excluded from this study based on the inclusion and exclusion criteria, 3 patients from the TXA-TAA group and 4 patients from the No TXA-TAA group.

Continue to: Charts were reviewed for demographics...

Charts were reviewed for demographics, preoperative and postoperative hemoglobin levels, indications for surgery, surgical procedures, length of surgery, postoperative drain output, length of stay, postoperative pain visual analog scale (VAS) score, minor and major wound complications, and postoperative complications. Minor wound complications were defined as the anterior surgical incision that required local wound care in office or oral antibiotics without subsequent consequences. Major wound complications were defined as requiring surgical débridement and/or any additional treatment in the operating room.¹⁶ Postoperative complications other than wound complications were defined as those requiring a subsequent surgical intervention. Patient demographics and clinical and procedural characteristics of patients in both the TXA-TAA and the No TXA-TAA groups are outlined in Table 1. There were 14 males and 11 females in the TXA-TAA group and 16 males and 9 females in the No TXA-TAA group. The mean age was 65.8 ± 10.9 years in the TXA-TAA group and 66.9 ± 8.0 years in the No TXA-TAA group (P = .69). Mean body mass index (BMI) was 31.6 ± 6.3 in the TXA-TAA group and 29.4 ± 4.9 in the No TXA-TAA group (P = .18). The primary indication for TAA was degenerative osteoarthritis in 26 patients, posttraumatic arthritis in 21 patients, and rheumatoid arthritis in 3 patients. The most common associated procedure was Achilles tendon lengthening in both groups. The mean follow-up in the TXA-TAA group was 9.3 ± 5.8 months (range, 2.0-24.0 months). Postoperative complications due to TXA administration as described in previous literature were defined as VTE, myocardial infarction, or ischemic cerebral event. The TXA-TAA group received a standard 1 g dose of IV TXA 20 minutes prior to tourniquet inflation. A tourniquet was used intraoperatively on all patients included in this study. A postoperative 400-mL surgical drain (Hemovac, Zimmer Biomet) was placed in the ankle joint in all patients and subsequently discontinued on postoperative day 1. Recent literature has reported the minor wound complication rate associated with TAA to be as high as 25% and the major wound complication rate to be 8.5%.¹⁶ To assist in reducing the risk for wound complications, our protocol traditionally uses an intra-articular surgical drain to decrease any pressure on the wound from postoperative hemarthrosis.

^aP value was calculated from t-test continuous variables and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).

Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index.

Total drain output was recorded in milliliters (mL) in all patients. The change between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1 was calculated for each patient. The calculated blood loss was determined using Meunier’s equation, which estimates the total blood volume using Nadler’s formula and then uses preoperative hemoglobin and postoperative day 1 hemoglobin values to calculate blood loss.^17,18 VAS scores (scale, 1-10) were obtained every 4 hours on postoperative day 1 according to the nursing protocol. The number 1 on the scale represents the least amount of pain, whereas 10 indicates the worst pain. The VAS scores were then averaged for each patient.

A power analysis using preliminary data determined that 15 patients were needed in each group to detect a 50% reduction in drain output at a power of 80% and a P value of 0.05. Descriptive statistics were used to analyze demographic data. We compared the demographic and clinical characteristics of patients in the TXA-TAA group with those of patients in the No TXA-TAA group using unpaired student t-tests for continuous variables and Chi-square or Fischer’s exact tests for categorical variables. Simple and adjusted linear regression analyses were used to examine the difference in drain output and blood loss between the 2 groups (TXA-TAA vs No TXA-TAA). Multivariate models were adjusted for age, BMI, and length of surgery. A P value <.05 was considered to be statistically significant. We performed all analyses using a statistical software package (SAS version 9.2, SAS Institute).

RESULTS

Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P = .0001) (Figure). The clinical characteristics of the patients who underwent TAA with the use of TXA are outlined in Table 2. The mean change in preoperative to postoperative hemoglobin levels was significantly lower in the TXA-TAA group than in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively; P = .01). The calculated blood loss in patients in the TXA-TAA group was significantly lower than that in patients in the No TXA-TAA group (649.9 ± 332.7 vs 906.8 ± 287.4 mL, respectively; P = .01). No patient in either group received a blood transfusion. We did not observe a significant difference in the length of surgery between the TXA-TAA and the No TXA-TAA groups (112.8 ± 24.8 vs 108.6 ± 26.0 min, respectively; P = .57). The average American Society of Anesthesiologists’ (ASA) classification was similar between the groups (2.2 ± 0.6 and 2.2 ± 0.5, respectively; P = 1.00) as was the age-adjusted Charlson Comorbidity Index (2.8 ± 1.7 vs 2.9 ± 1.6, respectively; P = .93). Mean VAS scores on postoperative day 1 in the TXA-TAA and the No TXA-TAA group were 4.9 ± 1.7 and 5.3 ± 1.4, respectively (P = .71). The average length of stay in the TXA-TAA group was 1.6 ± 0.7 days vs 1.3 ± 0.6 days in the No TXA-TAA group (P = .23). Two patients in the TXA-TAA group had an extended hospital length of stay of 5 days due to discharge planning and social issues.

^aP value was calculated from t-test for continuous variables, and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).

Abbreviations: LOS, length of stay; VAS, visual analog scale; POD, postoperative day.

^aLinear regression was used to calculate the P value. ^bAdjusted for age, BMI and length of surgery.

Abbreviation: BMI, body mass index.

^aP value was calculated from Fisher’s Exact test (67% cells had count <5) test for categorical variables (TXA-TAA vs No TXA-TAA comparison).

The crude linear regression model revealed a significant difference in drain output between the TXA-TAA and the No TXA-TAA groups (β = −128.6 ± 26.3, P < .0001) (Table 3). Further adjustment for age and length of surgery slightly strengthened the association (β = −129.6 ± 26.6, P < .0001). The nature of regression coefficient β showed that the mean estimate of drain output was 129.6 mL lower in the TXA-TAA group than that in the No TXA-TAA group. There was a significant difference in blood loss between the TXA-TAA and the No TXA-TAA groups in the crude linear regression model (β = −257.0 ± 87.9, P = .005). Additional adjustment for age, BMI, and length of surgery slightly strengthened the association (β = −275.6 ± 90.7, P = .004). The nature of regression coefficient β showed that the mean estimate of blood loss was 275.6 mL lower in the TXA-TAA group than in the No TXA-TAA group (Table 3).

Continue to: There was no statistically significant difference...

There was no statistically significant difference in wound complications between the TXA-TAA and the No TXA-TAA groups in this study population (P = .114). However, our results showed a higher overall wound complication rate in the No TXA-TAA group than in the TXA-TAA group (20% (5/25) vs 8% (2/25), respectively) (Table 4). In the No TXA-TAA group, there were 4 minor and 1 major wound complications. All 5 patients experiencing a postoperative wound complication required oral antibiotics for a minimum of 4 weeks and local wound care. One patient underwent a surgical débridement meeting the criteria for major wound complications. In the TXA-TAA group, there were 2 minor wound complications and no major wound complications. One patient was administered prophylactic oral antibiotics for 7 days with local wound care for blister formation without evidence of infection. The second patient experiencing a minor wound complication required 3 weeks of oral antibiotics and local wound care. No patients in either group had a deep infection requiring implant removal, IV antibiotics, or subsequent hospital admission. The surgical incisions in all patients healed after the aforementioned treatments with no persistent drainage or development of chronic wounds.

In the TXA-TAA group, there was 1 patient who sustained an intraoperative medial malleolus fracture. One patient developed an extensor hallucis longus contracture 5 months postoperatively that subsequently underwent release and lengthening. There was 1 patient in this group who sustained a distal tibia fracture 5 cm proximal to the prosthesis 3 months postoperatively after a mechanical fall. In the No TXA-TAA group, there were 2 patients who sustained intraoperative medial malleolus fractures. One patient underwent a revision of the tibial component 24 months postoperatively due to aseptic loosening. In addition, another patient in this group who sustained an Achilles tendon rupture 5 months postoperatively after a fall subsequently underwent repair with tibialis anterior tendon allograft.

There were no patients in either group who experienced any hospital readmissions in the acute follow-up period as defined by a 90-day period after discharge. There were no complications associated with TXA administration in either group.

DISCUSSION

Recent advances in total ankle prosthetic design coupled with increased survival and improved short- to midterm follow-up results make TAA an effective treatment option for end-stage ankle arthritis. Management of perioperative blood loss and reducing the potential for significant hemarthrosis and subsequent wound complications are important factors to consider for patients undergoing TAA. TXA administration is used in several centers as part of an intraoperative strategy to reduce blood loss and decrease intra-articular blood accumulation. To our knowledge, this is the first study to evaluate the management of blood loss and hemarthrosis using TXA during TAA.

IV and topical administrations of TXA have been demonstrated to be highly effective hemostatic agents in the perioperative period for TKA and THA.¹¹ Recent literature has demonstrated a significant reduction in drain output and mean change in preoperative to postoperative hemoglobin levels in patients who received TXA compared to that in patients who did not receive TXA. The patients who did not receive TXA had more than twice as much drain output.^{5,10,14,19-21}

Continue to: The ankle has a thin...

The ankle has a thin soft tissue envelope that does not have elaborate elastic properties. The soft tissue release and bleeding surfaces of the bone during TAA are not as extensive when compared with TKA and THA, but the intra-articular volume is smaller and the surrounding soft tissues may be less yielding when blood accumulation occurs.²² The vascular supply can be rich surrounding the ankle in the absence of arterial disease and is not as apt to tolerate dislocation and subluxation as in the case of THA or TKA.²³ Shear forces can easily tear the branches of the anterior tibial artery that lie within the fascia that is continuous with the periosteum on the distal tibia.²⁴ Reduction of hemarthrosis within the ankle joint may lead to a decrease in postoperative swelling, decreased pain, and increased range of motion due to the diminished potential for fibrosis. We also believe that there could be a reduced risk for wound complications. The current literature reports the rate of wound complications to be anywhere from 2% to 25%, with diabetes, inflammatory conditions, coronary artery disease, peripheral vascular disease, and smoking history >12-pack-years as risk factors.^16,25,26 In this study, we observed a significant reduction in drain output and an overall reduced percentage of postoperative wound complications in patients who received TXA. These results demonstrate that TXA use decreases postoperative hemarthrosis.

TXA use in TKA and THA has been shown to decrease direct hospital costs and hospital length of stay.^7,14,27 A recent study by Moskal and colleagues⁷ showed that topical TXA use has the potential to significantly decrease hospital man-hours for those patients undergoing TKA and achieve larger cost savings. Although there was no significant difference in the length of stay between the 2 groups, the average length of stay after TAA was shorter in both groups compared to the reported national average (1.49 vs 2.2 days, respectively).⁴ The administration of TXA in the appropriate patient has the potential to decrease hospital costs by controlling postoperative pain and swelling, allowing for earlier discharge. Long-term cost benefits could also include decreased infection rates and wound complications, and improved clinical outcomes because of improved range of motion and function scores.

The limitations of this study include the retrospective nature of its design and the relatively small sample size. The results showed nonstatistically significant differences in wound complications between the TXA-TAA and the No TXA-TAA groups, consistent with an insufficient sample size and thus inadequate power to detect the significant difference. However, this study clearly showed that the wound complication rates were higher in the No TXA-TAA group than in the TXA-TAA group, suggesting the importance of further similar studies using a larger sample size.

CONCLUSION

Current TAA offers a viable alternative to arthrodesis for end-stage ankle arthritis. TXA is an inexpensive and effective hemostatic agent used during TAA. If no major contraindication is present, routine use of TXA is recommended to assist in blood loss management, decrease postoperative hemarthrosis, and help to reduce the risk of postoperative wound complications.

ABSTRACT

Tranexamic acid (TXA) is an effective agent used for reducing perioperative blood loss and decreasing the potential for postoperative hemarthrosis. We hypothesized that patients who had received intraoperative TXA during total ankle arthroplasty (TAA) would have a reduction in postoperative drain output, thereby resulting in a reduced risk of postoperative hemarthrosis and lower wound complication rates.

A retrospective review was conducted on 50 consecutive patients, 25 receiving TXA (TXA-TAA) and 25 not receiving TXA (No TXA-TAA), who underwent an uncemented TAA between September 2011 and December 2015. Demographic characteristics, drain output, preoperative and postoperative hemoglobin levels, operative and postoperative course, and minor and major wound complications of the patients were reviewed.

Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P < .0001). The overall wound complication rate in the No TXA-TAA group was higher (20%, 5/25) than that in the TXA-TAA group (8%, 2/25) (P = .114). The mean change in preoperative to postoperative hemoglobin level was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively, P = .01).

TXA is an effective hemostatic agent when used during TAA. TXA reduces perioperative blood loss, hemarthrosis, and the risk of wound complications.

Continue to: End-stage ankle arthritis...

End-stage ankle arthritis is a disabling condition that may lead to poor quality of life and difficulties with activities of daily living.¹ The associated mental and physical disability has been demonstrated to be as severe as in end-stage hip arthrosis.² Operative treatment for symptomatic end-stage ankle arthritis includes arthrodesis or total ankle arthroplasty (TAA) in those refractory to nonoperative treatment.³ Newer generation implants have made TAA a more attractive option for both the surgeon and the patient.

Over the past decade, the utility of TAA has increased and attention has turned toward the management of perioperative factors that would maximize patient satisfaction and decrease the length of stay and complication rates, as well as hospital costs.⁴ Comprehensive literature on total knee arthroplasty (TKA) and total hip arthroplasty (THA) has demonstrated that the management of perioperative blood loss, specifically postoperative hemarthrosis, is a modifiable factor affecting patient recovery, complication rates, and hospital costs.^5-8 Drain output has been used as a direct measure of intra-articular blood accumulation.⁹ Decreased drain output implies decreased hemarthrosis, which could potentially alleviate the pressure on the wound and decrease wound complications.

One of the major strategies that has been recognized for reducing blood loss and decreasing the potential for postoperative hemarthrosis is the use of intravenous (IV) or topical tranexamic acid (TXA).^10,11 TXA is a synthetic antifibrinolytic medication that has been extensively used throughout the medical field since the 1960s to help control the bleeding cascade. This medication stabilizes clot formation without inducing a pro-coaguable state.¹² Intraoperative administration of TXA has been shown to reduce drain output and decrease transfusion requirements after TKA and THA without an associated increase in patient morbidity and mortality.^6,11,13-15

Currently, there is a lack of studies evaluating the utility of TXA during TAA. We hypothesize that compared with patients who had not received TXA, those who had received intraoperative TXA during TAA would have a reduction in postoperative drain output and therefore decreased hemarthrosis, lower wound complication rate, and a diminished change in preoperative to postoperative hemoglobin levels, reflecting a reduction in perioperative blood loss.

MATERIALS AND METHODS

This study was approved by the Institutional Review Board at the University at Buffalo, State University of New York. A retrospective chart review was conducted on 50 consecutive patients who underwent an uncemented TAA with the Salto Talaris total ankle prosthesis (Tornier, Inc) between September 2011 and December 2015. All surgeries were performed at 1 institution by a single fellowship surgeon trained in foot and ankle surgery through the anterior approach where a midline incision was made over the ankle. The interval between the tibialis anterior tendon and the extensor hallucis longus tendon was used. We had incorporated intraoperative TXA into the TAA surgical protocol at our institution in January 2014. We evaluated the first 25 consecutive patients who underwent TAA after TXA use began (TXA-TAA) and another 25 consecutive patients who underwent TAA before the routine use of TXA (No TXA-TAA). Inclusion criteria were patients who presented with pain, decreased function, and radiographic parameters of end-stage tibiotalar arthritis due to degenerative arthritis, rheumatoid arthritis, or posttraumatic arthritis who subsequently underwent a TAA. Exclusion criteria were patients with a contraindication for IV TXA use, a preexisting coagulopathy, or where drain output was not recorded. Contraindications for IV TXA use included patients with impaired renal clearance, recent cardiac surgery, myocardial infarction, ischemic stroke, or venous thromboembolism (VTE). Seven patients were ultimately excluded from this study based on the inclusion and exclusion criteria, 3 patients from the TXA-TAA group and 4 patients from the No TXA-TAA group.

Continue to: Charts were reviewed for demographics...

Charts were reviewed for demographics, preoperative and postoperative hemoglobin levels, indications for surgery, surgical procedures, length of surgery, postoperative drain output, length of stay, postoperative pain visual analog scale (VAS) score, minor and major wound complications, and postoperative complications. Minor wound complications were defined as the anterior surgical incision that required local wound care in office or oral antibiotics without subsequent consequences. Major wound complications were defined as requiring surgical débridement and/or any additional treatment in the operating room.¹⁶ Postoperative complications other than wound complications were defined as those requiring a subsequent surgical intervention. Patient demographics and clinical and procedural characteristics of patients in both the TXA-TAA and the No TXA-TAA groups are outlined in Table 1. There were 14 males and 11 females in the TXA-TAA group and 16 males and 9 females in the No TXA-TAA group. The mean age was 65.8 ± 10.9 years in the TXA-TAA group and 66.9 ± 8.0 years in the No TXA-TAA group (P = .69). Mean body mass index (BMI) was 31.6 ± 6.3 in the TXA-TAA group and 29.4 ± 4.9 in the No TXA-TAA group (P = .18). The primary indication for TAA was degenerative osteoarthritis in 26 patients, posttraumatic arthritis in 21 patients, and rheumatoid arthritis in 3 patients. The most common associated procedure was Achilles tendon lengthening in both groups. The mean follow-up in the TXA-TAA group was 9.3 ± 5.8 months (range, 2.0-24.0 months). Postoperative complications due to TXA administration as described in previous literature were defined as VTE, myocardial infarction, or ischemic cerebral event. The TXA-TAA group received a standard 1 g dose of IV TXA 20 minutes prior to tourniquet inflation. A tourniquet was used intraoperatively on all patients included in this study. A postoperative 400-mL surgical drain (Hemovac, Zimmer Biomet) was placed in the ankle joint in all patients and subsequently discontinued on postoperative day 1. Recent literature has reported the minor wound complication rate associated with TAA to be as high as 25% and the major wound complication rate to be 8.5%.¹⁶ To assist in reducing the risk for wound complications, our protocol traditionally uses an intra-articular surgical drain to decrease any pressure on the wound from postoperative hemarthrosis.

^aP value was calculated from t-test continuous variables and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).

Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index.

Total drain output was recorded in milliliters (mL) in all patients. The change between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1 was calculated for each patient. The calculated blood loss was determined using Meunier’s equation, which estimates the total blood volume using Nadler’s formula and then uses preoperative hemoglobin and postoperative day 1 hemoglobin values to calculate blood loss.^17,18 VAS scores (scale, 1-10) were obtained every 4 hours on postoperative day 1 according to the nursing protocol. The number 1 on the scale represents the least amount of pain, whereas 10 indicates the worst pain. The VAS scores were then averaged for each patient.

A power analysis using preliminary data determined that 15 patients were needed in each group to detect a 50% reduction in drain output at a power of 80% and a P value of 0.05. Descriptive statistics were used to analyze demographic data. We compared the demographic and clinical characteristics of patients in the TXA-TAA group with those of patients in the No TXA-TAA group using unpaired student t-tests for continuous variables and Chi-square or Fischer’s exact tests for categorical variables. Simple and adjusted linear regression analyses were used to examine the difference in drain output and blood loss between the 2 groups (TXA-TAA vs No TXA-TAA). Multivariate models were adjusted for age, BMI, and length of surgery. A P value <.05 was considered to be statistically significant. We performed all analyses using a statistical software package (SAS version 9.2, SAS Institute).

RESULTS

Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P = .0001) (Figure). The clinical characteristics of the patients who underwent TAA with the use of TXA are outlined in Table 2. The mean change in preoperative to postoperative hemoglobin levels was significantly lower in the TXA-TAA group than in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively; P = .01). The calculated blood loss in patients in the TXA-TAA group was significantly lower than that in patients in the No TXA-TAA group (649.9 ± 332.7 vs 906.8 ± 287.4 mL, respectively; P = .01). No patient in either group received a blood transfusion. We did not observe a significant difference in the length of surgery between the TXA-TAA and the No TXA-TAA groups (112.8 ± 24.8 vs 108.6 ± 26.0 min, respectively; P = .57). The average American Society of Anesthesiologists’ (ASA) classification was similar between the groups (2.2 ± 0.6 and 2.2 ± 0.5, respectively; P = 1.00) as was the age-adjusted Charlson Comorbidity Index (2.8 ± 1.7 vs 2.9 ± 1.6, respectively; P = .93). Mean VAS scores on postoperative day 1 in the TXA-TAA and the No TXA-TAA group were 4.9 ± 1.7 and 5.3 ± 1.4, respectively (P = .71). The average length of stay in the TXA-TAA group was 1.6 ± 0.7 days vs 1.3 ± 0.6 days in the No TXA-TAA group (P = .23). Two patients in the TXA-TAA group had an extended hospital length of stay of 5 days due to discharge planning and social issues.

^aP value was calculated from t-test for continuous variables, and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).

Abbreviations: LOS, length of stay; VAS, visual analog scale; POD, postoperative day.

^aLinear regression was used to calculate the P value. ^bAdjusted for age, BMI and length of surgery.

Abbreviation: BMI, body mass index.

^aP value was calculated from Fisher’s Exact test (67% cells had count <5) test for categorical variables (TXA-TAA vs No TXA-TAA comparison).

The crude linear regression model revealed a significant difference in drain output between the TXA-TAA and the No TXA-TAA groups (β = −128.6 ± 26.3, P < .0001) (Table 3). Further adjustment for age and length of surgery slightly strengthened the association (β = −129.6 ± 26.6, P < .0001). The nature of regression coefficient β showed that the mean estimate of drain output was 129.6 mL lower in the TXA-TAA group than that in the No TXA-TAA group. There was a significant difference in blood loss between the TXA-TAA and the No TXA-TAA groups in the crude linear regression model (β = −257.0 ± 87.9, P = .005). Additional adjustment for age, BMI, and length of surgery slightly strengthened the association (β = −275.6 ± 90.7, P = .004). The nature of regression coefficient β showed that the mean estimate of blood loss was 275.6 mL lower in the TXA-TAA group than in the No TXA-TAA group (Table 3).

Continue to: There was no statistically significant difference...

There was no statistically significant difference in wound complications between the TXA-TAA and the No TXA-TAA groups in this study population (P = .114). However, our results showed a higher overall wound complication rate in the No TXA-TAA group than in the TXA-TAA group (20% (5/25) vs 8% (2/25), respectively) (Table 4). In the No TXA-TAA group, there were 4 minor and 1 major wound complications. All 5 patients experiencing a postoperative wound complication required oral antibiotics for a minimum of 4 weeks and local wound care. One patient underwent a surgical débridement meeting the criteria for major wound complications. In the TXA-TAA group, there were 2 minor wound complications and no major wound complications. One patient was administered prophylactic oral antibiotics for 7 days with local wound care for blister formation without evidence of infection. The second patient experiencing a minor wound complication required 3 weeks of oral antibiotics and local wound care. No patients in either group had a deep infection requiring implant removal, IV antibiotics, or subsequent hospital admission. The surgical incisions in all patients healed after the aforementioned treatments with no persistent drainage or development of chronic wounds.

In the TXA-TAA group, there was 1 patient who sustained an intraoperative medial malleolus fracture. One patient developed an extensor hallucis longus contracture 5 months postoperatively that subsequently underwent release and lengthening. There was 1 patient in this group who sustained a distal tibia fracture 5 cm proximal to the prosthesis 3 months postoperatively after a mechanical fall. In the No TXA-TAA group, there were 2 patients who sustained intraoperative medial malleolus fractures. One patient underwent a revision of the tibial component 24 months postoperatively due to aseptic loosening. In addition, another patient in this group who sustained an Achilles tendon rupture 5 months postoperatively after a fall subsequently underwent repair with tibialis anterior tendon allograft.

There were no patients in either group who experienced any hospital readmissions in the acute follow-up period as defined by a 90-day period after discharge. There were no complications associated with TXA administration in either group.

DISCUSSION

Recent advances in total ankle prosthetic design coupled with increased survival and improved short- to midterm follow-up results make TAA an effective treatment option for end-stage ankle arthritis. Management of perioperative blood loss and reducing the potential for significant hemarthrosis and subsequent wound complications are important factors to consider for patients undergoing TAA. TXA administration is used in several centers as part of an intraoperative strategy to reduce blood loss and decrease intra-articular blood accumulation. To our knowledge, this is the first study to evaluate the management of blood loss and hemarthrosis using TXA during TAA.

IV and topical administrations of TXA have been demonstrated to be highly effective hemostatic agents in the perioperative period for TKA and THA.¹¹ Recent literature has demonstrated a significant reduction in drain output and mean change in preoperative to postoperative hemoglobin levels in patients who received TXA compared to that in patients who did not receive TXA. The patients who did not receive TXA had more than twice as much drain output.^{5,10,14,19-21}

Continue to: The ankle has a thin...

The ankle has a thin soft tissue envelope that does not have elaborate elastic properties. The soft tissue release and bleeding surfaces of the bone during TAA are not as extensive when compared with TKA and THA, but the intra-articular volume is smaller and the surrounding soft tissues may be less yielding when blood accumulation occurs.²² The vascular supply can be rich surrounding the ankle in the absence of arterial disease and is not as apt to tolerate dislocation and subluxation as in the case of THA or TKA.²³ Shear forces can easily tear the branches of the anterior tibial artery that lie within the fascia that is continuous with the periosteum on the distal tibia.²⁴ Reduction of hemarthrosis within the ankle joint may lead to a decrease in postoperative swelling, decreased pain, and increased range of motion due to the diminished potential for fibrosis. We also believe that there could be a reduced risk for wound complications. The current literature reports the rate of wound complications to be anywhere from 2% to 25%, with diabetes, inflammatory conditions, coronary artery disease, peripheral vascular disease, and smoking history >12-pack-years as risk factors.^16,25,26 In this study, we observed a significant reduction in drain output and an overall reduced percentage of postoperative wound complications in patients who received TXA. These results demonstrate that TXA use decreases postoperative hemarthrosis.

TXA use in TKA and THA has been shown to decrease direct hospital costs and hospital length of stay.^7,14,27 A recent study by Moskal and colleagues⁷ showed that topical TXA use has the potential to significantly decrease hospital man-hours for those patients undergoing TKA and achieve larger cost savings. Although there was no significant difference in the length of stay between the 2 groups, the average length of stay after TAA was shorter in both groups compared to the reported national average (1.49 vs 2.2 days, respectively).⁴ The administration of TXA in the appropriate patient has the potential to decrease hospital costs by controlling postoperative pain and swelling, allowing for earlier discharge. Long-term cost benefits could also include decreased infection rates and wound complications, and improved clinical outcomes because of improved range of motion and function scores.

The limitations of this study include the retrospective nature of its design and the relatively small sample size. The results showed nonstatistically significant differences in wound complications between the TXA-TAA and the No TXA-TAA groups, consistent with an insufficient sample size and thus inadequate power to detect the significant difference. However, this study clearly showed that the wound complication rates were higher in the No TXA-TAA group than in the TXA-TAA group, suggesting the importance of further similar studies using a larger sample size.

CONCLUSION

Current TAA offers a viable alternative to arthrodesis for end-stage ankle arthritis. TXA is an inexpensive and effective hemostatic agent used during TAA. If no major contraindication is present, routine use of TXA is recommended to assist in blood loss management, decrease postoperative hemarthrosis, and help to reduce the risk of postoperative wound complications.

ABSTRACT

Tranexamic acid (TXA) is an effective agent used for reducing perioperative blood loss and decreasing the potential for postoperative hemarthrosis. We hypothesized that patients who had received intraoperative TXA during total ankle arthroplasty (TAA) would have a reduction in postoperative drain output, thereby resulting in a reduced risk of postoperative hemarthrosis and lower wound complication rates.

A retrospective review was conducted on 50 consecutive patients, 25 receiving TXA (TXA-TAA) and 25 not receiving TXA (No TXA-TAA), who underwent an uncemented TAA between September 2011 and December 2015. Demographic characteristics, drain output, preoperative and postoperative hemoglobin levels, operative and postoperative course, and minor and major wound complications of the patients were reviewed.

Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P < .0001). The overall wound complication rate in the No TXA-TAA group was higher (20%, 5/25) than that in the TXA-TAA group (8%, 2/25) (P = .114). The mean change in preoperative to postoperative hemoglobin level was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively, P = .01).

TXA is an effective hemostatic agent when used during TAA. TXA reduces perioperative blood loss, hemarthrosis, and the risk of wound complications.

Continue to: End-stage ankle arthritis...

End-stage ankle arthritis is a disabling condition that may lead to poor quality of life and difficulties with activities of daily living.¹ The associated mental and physical disability has been demonstrated to be as severe as in end-stage hip arthrosis.² Operative treatment for symptomatic end-stage ankle arthritis includes arthrodesis or total ankle arthroplasty (TAA) in those refractory to nonoperative treatment.³ Newer generation implants have made TAA a more attractive option for both the surgeon and the patient.

Over the past decade, the utility of TAA has increased and attention has turned toward the management of perioperative factors that would maximize patient satisfaction and decrease the length of stay and complication rates, as well as hospital costs.⁴ Comprehensive literature on total knee arthroplasty (TKA) and total hip arthroplasty (THA) has demonstrated that the management of perioperative blood loss, specifically postoperative hemarthrosis, is a modifiable factor affecting patient recovery, complication rates, and hospital costs.^5-8 Drain output has been used as a direct measure of intra-articular blood accumulation.⁹ Decreased drain output implies decreased hemarthrosis, which could potentially alleviate the pressure on the wound and decrease wound complications.

One of the major strategies that has been recognized for reducing blood loss and decreasing the potential for postoperative hemarthrosis is the use of intravenous (IV) or topical tranexamic acid (TXA).^10,11 TXA is a synthetic antifibrinolytic medication that has been extensively used throughout the medical field since the 1960s to help control the bleeding cascade. This medication stabilizes clot formation without inducing a pro-coaguable state.¹² Intraoperative administration of TXA has been shown to reduce drain output and decrease transfusion requirements after TKA and THA without an associated increase in patient morbidity and mortality.^6,11,13-15

Currently, there is a lack of studies evaluating the utility of TXA during TAA. We hypothesize that compared with patients who had not received TXA, those who had received intraoperative TXA during TAA would have a reduction in postoperative drain output and therefore decreased hemarthrosis, lower wound complication rate, and a diminished change in preoperative to postoperative hemoglobin levels, reflecting a reduction in perioperative blood loss.

MATERIALS AND METHODS

This study was approved by the Institutional Review Board at the University at Buffalo, State University of New York. A retrospective chart review was conducted on 50 consecutive patients who underwent an uncemented TAA with the Salto Talaris total ankle prosthesis (Tornier, Inc) between September 2011 and December 2015. All surgeries were performed at 1 institution by a single fellowship surgeon trained in foot and ankle surgery through the anterior approach where a midline incision was made over the ankle. The interval between the tibialis anterior tendon and the extensor hallucis longus tendon was used. We had incorporated intraoperative TXA into the TAA surgical protocol at our institution in January 2014. We evaluated the first 25 consecutive patients who underwent TAA after TXA use began (TXA-TAA) and another 25 consecutive patients who underwent TAA before the routine use of TXA (No TXA-TAA). Inclusion criteria were patients who presented with pain, decreased function, and radiographic parameters of end-stage tibiotalar arthritis due to degenerative arthritis, rheumatoid arthritis, or posttraumatic arthritis who subsequently underwent a TAA. Exclusion criteria were patients with a contraindication for IV TXA use, a preexisting coagulopathy, or where drain output was not recorded. Contraindications for IV TXA use included patients with impaired renal clearance, recent cardiac surgery, myocardial infarction, ischemic stroke, or venous thromboembolism (VTE). Seven patients were ultimately excluded from this study based on the inclusion and exclusion criteria, 3 patients from the TXA-TAA group and 4 patients from the No TXA-TAA group.

Continue to: Charts were reviewed for demographics...

Charts were reviewed for demographics, preoperative and postoperative hemoglobin levels, indications for surgery, surgical procedures, length of surgery, postoperative drain output, length of stay, postoperative pain visual analog scale (VAS) score, minor and major wound complications, and postoperative complications. Minor wound complications were defined as the anterior surgical incision that required local wound care in office or oral antibiotics without subsequent consequences. Major wound complications were defined as requiring surgical débridement and/or any additional treatment in the operating room.¹⁶ Postoperative complications other than wound complications were defined as those requiring a subsequent surgical intervention. Patient demographics and clinical and procedural characteristics of patients in both the TXA-TAA and the No TXA-TAA groups are outlined in Table 1. There were 14 males and 11 females in the TXA-TAA group and 16 males and 9 females in the No TXA-TAA group. The mean age was 65.8 ± 10.9 years in the TXA-TAA group and 66.9 ± 8.0 years in the No TXA-TAA group (P = .69). Mean body mass index (BMI) was 31.6 ± 6.3 in the TXA-TAA group and 29.4 ± 4.9 in the No TXA-TAA group (P = .18). The primary indication for TAA was degenerative osteoarthritis in 26 patients, posttraumatic arthritis in 21 patients, and rheumatoid arthritis in 3 patients. The most common associated procedure was Achilles tendon lengthening in both groups. The mean follow-up in the TXA-TAA group was 9.3 ± 5.8 months (range, 2.0-24.0 months). Postoperative complications due to TXA administration as described in previous literature were defined as VTE, myocardial infarction, or ischemic cerebral event. The TXA-TAA group received a standard 1 g dose of IV TXA 20 minutes prior to tourniquet inflation. A tourniquet was used intraoperatively on all patients included in this study. A postoperative 400-mL surgical drain (Hemovac, Zimmer Biomet) was placed in the ankle joint in all patients and subsequently discontinued on postoperative day 1. Recent literature has reported the minor wound complication rate associated with TAA to be as high as 25% and the major wound complication rate to be 8.5%.¹⁶ To assist in reducing the risk for wound complications, our protocol traditionally uses an intra-articular surgical drain to decrease any pressure on the wound from postoperative hemarthrosis.

^aP value was calculated from t-test continuous variables and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).

Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index.

Total drain output was recorded in milliliters (mL) in all patients. The change between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1 was calculated for each patient. The calculated blood loss was determined using Meunier’s equation, which estimates the total blood volume using Nadler’s formula and then uses preoperative hemoglobin and postoperative day 1 hemoglobin values to calculate blood loss.^17,18 VAS scores (scale, 1-10) were obtained every 4 hours on postoperative day 1 according to the nursing protocol. The number 1 on the scale represents the least amount of pain, whereas 10 indicates the worst pain. The VAS scores were then averaged for each patient.

A power analysis using preliminary data determined that 15 patients were needed in each group to detect a 50% reduction in drain output at a power of 80% and a P value of 0.05. Descriptive statistics were used to analyze demographic data. We compared the demographic and clinical characteristics of patients in the TXA-TAA group with those of patients in the No TXA-TAA group using unpaired student t-tests for continuous variables and Chi-square or Fischer’s exact tests for categorical variables. Simple and adjusted linear regression analyses were used to examine the difference in drain output and blood loss between the 2 groups (TXA-TAA vs No TXA-TAA). Multivariate models were adjusted for age, BMI, and length of surgery. A P value <.05 was considered to be statistically significant. We performed all analyses using a statistical software package (SAS version 9.2, SAS Institute).

RESULTS

Drain output was significantly less in the TXA-TAA group compared to that in the No TXA-TAA group (71.6 ± 60.3 vs 200.2 ± 117.0 mL, respectively, P = .0001) (Figure). The clinical characteristics of the patients who underwent TAA with the use of TXA are outlined in Table 2. The mean change in preoperative to postoperative hemoglobin levels was significantly lower in the TXA-TAA group than in the No TXA-TAA group (1.5 ± 0.6 vs 2.0 ± 0.4 g/dL, respectively; P = .01). The calculated blood loss in patients in the TXA-TAA group was significantly lower than that in patients in the No TXA-TAA group (649.9 ± 332.7 vs 906.8 ± 287.4 mL, respectively; P = .01). No patient in either group received a blood transfusion. We did not observe a significant difference in the length of surgery between the TXA-TAA and the No TXA-TAA groups (112.8 ± 24.8 vs 108.6 ± 26.0 min, respectively; P = .57). The average American Society of Anesthesiologists’ (ASA) classification was similar between the groups (2.2 ± 0.6 and 2.2 ± 0.5, respectively; P = 1.00) as was the age-adjusted Charlson Comorbidity Index (2.8 ± 1.7 vs 2.9 ± 1.6, respectively; P = .93). Mean VAS scores on postoperative day 1 in the TXA-TAA and the No TXA-TAA group were 4.9 ± 1.7 and 5.3 ± 1.4, respectively (P = .71). The average length of stay in the TXA-TAA group was 1.6 ± 0.7 days vs 1.3 ± 0.6 days in the No TXA-TAA group (P = .23). Two patients in the TXA-TAA group had an extended hospital length of stay of 5 days due to discharge planning and social issues.

^aP value was calculated from t-test for continuous variables, and Chi-square test for categorical variables (TXA-TAA vs No TXA-TAA comparison).

Abbreviations: LOS, length of stay; VAS, visual analog scale; POD, postoperative day.

^aLinear regression was used to calculate the P value. ^bAdjusted for age, BMI and length of surgery.

Abbreviation: BMI, body mass index.

^aP value was calculated from Fisher’s Exact test (67% cells had count <5) test for categorical variables (TXA-TAA vs No TXA-TAA comparison).

The crude linear regression model revealed a significant difference in drain output between the TXA-TAA and the No TXA-TAA groups (β = −128.6 ± 26.3, P < .0001) (Table 3). Further adjustment for age and length of surgery slightly strengthened the association (β = −129.6 ± 26.6, P < .0001). The nature of regression coefficient β showed that the mean estimate of drain output was 129.6 mL lower in the TXA-TAA group than that in the No TXA-TAA group. There was a significant difference in blood loss between the TXA-TAA and the No TXA-TAA groups in the crude linear regression model (β = −257.0 ± 87.9, P = .005). Additional adjustment for age, BMI, and length of surgery slightly strengthened the association (β = −275.6 ± 90.7, P = .004). The nature of regression coefficient β showed that the mean estimate of blood loss was 275.6 mL lower in the TXA-TAA group than in the No TXA-TAA group (Table 3).

Continue to: There was no statistically significant difference...

There was no statistically significant difference in wound complications between the TXA-TAA and the No TXA-TAA groups in this study population (P = .114). However, our results showed a higher overall wound complication rate in the No TXA-TAA group than in the TXA-TAA group (20% (5/25) vs 8% (2/25), respectively) (Table 4). In the No TXA-TAA group, there were 4 minor and 1 major wound complications. All 5 patients experiencing a postoperative wound complication required oral antibiotics for a minimum of 4 weeks and local wound care. One patient underwent a surgical débridement meeting the criteria for major wound complications. In the TXA-TAA group, there were 2 minor wound complications and no major wound complications. One patient was administered prophylactic oral antibiotics for 7 days with local wound care for blister formation without evidence of infection. The second patient experiencing a minor wound complication required 3 weeks of oral antibiotics and local wound care. No patients in either group had a deep infection requiring implant removal, IV antibiotics, or subsequent hospital admission. The surgical incisions in all patients healed after the aforementioned treatments with no persistent drainage or development of chronic wounds.

In the TXA-TAA group, there was 1 patient who sustained an intraoperative medial malleolus fracture. One patient developed an extensor hallucis longus contracture 5 months postoperatively that subsequently underwent release and lengthening. There was 1 patient in this group who sustained a distal tibia fracture 5 cm proximal to the prosthesis 3 months postoperatively after a mechanical fall. In the No TXA-TAA group, there were 2 patients who sustained intraoperative medial malleolus fractures. One patient underwent a revision of the tibial component 24 months postoperatively due to aseptic loosening. In addition, another patient in this group who sustained an Achilles tendon rupture 5 months postoperatively after a fall subsequently underwent repair with tibialis anterior tendon allograft.

There were no patients in either group who experienced any hospital readmissions in the acute follow-up period as defined by a 90-day period after discharge. There were no complications associated with TXA administration in either group.

DISCUSSION

Recent advances in total ankle prosthetic design coupled with increased survival and improved short- to midterm follow-up results make TAA an effective treatment option for end-stage ankle arthritis. Management of perioperative blood loss and reducing the potential for significant hemarthrosis and subsequent wound complications are important factors to consider for patients undergoing TAA. TXA administration is used in several centers as part of an intraoperative strategy to reduce blood loss and decrease intra-articular blood accumulation. To our knowledge, this is the first study to evaluate the management of blood loss and hemarthrosis using TXA during TAA.

IV and topical administrations of TXA have been demonstrated to be highly effective hemostatic agents in the perioperative period for TKA and THA.¹¹ Recent literature has demonstrated a significant reduction in drain output and mean change in preoperative to postoperative hemoglobin levels in patients who received TXA compared to that in patients who did not receive TXA. The patients who did not receive TXA had more than twice as much drain output.^{5,10,14,19-21}

Continue to: The ankle has a thin...

The ankle has a thin soft tissue envelope that does not have elaborate elastic properties. The soft tissue release and bleeding surfaces of the bone during TAA are not as extensive when compared with TKA and THA, but the intra-articular volume is smaller and the surrounding soft tissues may be less yielding when blood accumulation occurs.²² The vascular supply can be rich surrounding the ankle in the absence of arterial disease and is not as apt to tolerate dislocation and subluxation as in the case of THA or TKA.²³ Shear forces can easily tear the branches of the anterior tibial artery that lie within the fascia that is continuous with the periosteum on the distal tibia.²⁴ Reduction of hemarthrosis within the ankle joint may lead to a decrease in postoperative swelling, decreased pain, and increased range of motion due to the diminished potential for fibrosis. We also believe that there could be a reduced risk for wound complications. The current literature reports the rate of wound complications to be anywhere from 2% to 25%, with diabetes, inflammatory conditions, coronary artery disease, peripheral vascular disease, and smoking history >12-pack-years as risk factors.^16,25,26 In this study, we observed a significant reduction in drain output and an overall reduced percentage of postoperative wound complications in patients who received TXA. These results demonstrate that TXA use decreases postoperative hemarthrosis.

TXA use in TKA and THA has been shown to decrease direct hospital costs and hospital length of stay.^7,14,27 A recent study by Moskal and colleagues⁷ showed that topical TXA use has the potential to significantly decrease hospital man-hours for those patients undergoing TKA and achieve larger cost savings. Although there was no significant difference in the length of stay between the 2 groups, the average length of stay after TAA was shorter in both groups compared to the reported national average (1.49 vs 2.2 days, respectively).⁴ The administration of TXA in the appropriate patient has the potential to decrease hospital costs by controlling postoperative pain and swelling, allowing for earlier discharge. Long-term cost benefits could also include decreased infection rates and wound complications, and improved clinical outcomes because of improved range of motion and function scores.

The limitations of this study include the retrospective nature of its design and the relatively small sample size. The results showed nonstatistically significant differences in wound complications between the TXA-TAA and the No TXA-TAA groups, consistent with an insufficient sample size and thus inadequate power to detect the significant difference. However, this study clearly showed that the wound complication rates were higher in the No TXA-TAA group than in the TXA-TAA group, suggesting the importance of further similar studies using a larger sample size.

CONCLUSION

Current TAA offers a viable alternative to arthrodesis for end-stage ankle arthritis. TXA is an inexpensive and effective hemostatic agent used during TAA. If no major contraindication is present, routine use of TXA is recommended to assist in blood loss management, decrease postoperative hemarthrosis, and help to reduce the risk of postoperative wound complications.

ABSTRACT

This case shows an atypical presentation of an osteochondritis dissecans (OCD) lesion of the radial head with detachment diagnosed on plain radiographs and magnetic resonance imaging (MRI). OCD lesions are rather uncommon in the elbow joint; however, when present, these lesions are typically seen in throwing athletes or gymnasts who engage in activities involving repetitive trauma to the elbow. Involvement of the radial head is extremely rare, accounting for <5% of all elbow OCD lesions. Conventional radiographs have low sensitivity for detecting OCD lesions and may frequently miss these lesions in the early stages. MRI, the imaging modality of choice, can detect these lesions at the earliest stage and provide a clear picture of the involved articular cartilage and underlying bone. Treatment options can vary between nonoperative and operative management depending on several factors, including age and activity level of the patient, size and type of lesion, and clinical presentation. This case represents a radial head OCD lesion managed by arthroscopic débridement alone, resulting in a positive outcome.

Continue to: Case Report...

CASE REPORT

A healthy, 14-year-old, left-hand-dominant adolescent boy presented to the office with a chief complaint of pain localized to the posterolateral aspect of his elbow. He described an injury where he felt a “pop” in his elbow followed by immediate pain in the posterolateral elbow after throwing a pitch during a baseball game. Since the injury, the patient had experienced difficulty extending his elbow and a sharp, throbbing pain during forearm rotation. The patient also reported an intermittent clicking feeling in the elbow. Prior to this injury, he had no elbow pain. He presented in an otherwise normal state of health with no reported past medical or surgical history and no previous trauma to the left upper extremity.

Physical examination demonstrated a mild effusion of the left elbow in the region of the posterolateral corner or “soft spot” with tenderness to palpation over the radial head. The patient had restricted elbow motion with 30° to 135° of flexion. He had 90° of pronation and supination. Ligamentous examination revealed stability of the elbow to both varus and valgus stress at 30° of flexion. No deficits were observed upon upper-extremity neurovascular examination.

Plain radiographs of the left elbow were initially taken. Anteroposterior, lateral, and Greenspan views revealed evidence of a displaced osteochondral fragment of the radial head in this skeletally immature patient. No involvement of the capitellum was apparent (Figures 1A-1C). Non-contrast magnetic resonance imaging (MRI) of the left elbow was subsequently obtained to evaluate the lesion further, and the images confirmed an unstable osteochondritis dissecans (OCD) lesion of the radial head with a detached fragment entrapped within the elbow joint (Figures 2A-2E).

Elbow arthroscopy was performed to evaluate the extent of the OCD lesion to enable determination of the integrity of the cartilaginous surface and remove the loose body entrapped within the elbow joint. Multiple loose bodies (all <5 mm in size) were removed from the elbow joint. Visualization of the radiocapitellar joint revealed extensive cartilage damage to the radial head with multiple areas of denuded cartilage and exposed bone. The main chondral defect measured approximately 4 mm in size. Probing of the lesion confirmed no stable edge; thus, abrasion arthroplasty was performed to stabilize the lesion and stimulate future fibrous cartilage growth (Figures 3A, 3B).

The patient was started on physical therapy consisting of active and active-assisted elbow ranges of motion on postoperative day 10. At the 6-week follow up, the patient presented to the office with pain-free motion of the left elbow ranging from −5° to 135° of flexion. He maintained full pronation and supination. At this point, the patient was advised to begin a throwing program. Three months after treatment, the patient resumed baseball activities, including throwing, with pain-free, full range of motion of the elbow. The patient and the patient’s parents provided written informed consent for print and electronic publication of this case report.

Continue to: Discussion...

DISCUSSION

Elbow pain is a common complaint among young baseball players. OCD lesions, however, are an uncommon entity associated with elbow pathology.¹ The overall incidence of OCD lesions is between 15 to 30 per 100,000 people.^2-3 Specifically in patients aged 2 to 19 years, the incidence of elbow OCD lesions is 2.2 per 100,000 patients and 3.8 and 0.6 per 100,000 for males and females, respectively.⁴ Radial head OCD lesions are extremely rare, occurring in <5% of all elbow OCD cases.¹ The majority of these lesions are asymptomatic and typically seen in patients who engage in repetitive overhead and upper-extremity weight-bearing activities. Reports indicate that the incidence of these lesions is on the rise and the age of presentation is decreasing, likely because of increased awareness of the disease and increasing involvement of young athletes in competitive athletics.^4-5 Most patients with elbow OCD have a history of repetitive overuse of the elbow, as seen in baseball players, leading to excessive compressive and shear forces across the radiocapitellar joint and progression of the dissecans lesion.⁶

Patients with OCD lesions of the elbow typically present with inflammatory type symptoms and lateral elbow pain. The pain tends to be mild at rest and becomes more pronounced with activity. Patients often wait until mechanical symptoms ensue (eg, clicking, catching, or locking) before presenting to the office. On physical examination, pain in the region of the OCD lesion is usually accompanied by a mild effusion. Stiffness, particularly a loss of terminal extension, may accompany the mechanical symptoms on range of motion testing.⁷

Workup of elbow OCD lesions begins with obtaining plain radiographs of the elbow. Plain films are of limited use in evaluating these lesions but can help determine separation and the approximate size of the fragment.⁸ Further work-up must include MRI sequences, which allow for the best evaluation of the articular cartilage, underlying bone, and, specifically, the size and degree of separation of the OCD lesion.⁹

Nonoperative treatment of OCD lesions is usually successful if diagnosed early. Such treatment consists of activity modification, rest, anti-inflammatory medications, and a gradual return to athletic activities over the next 3 to 6 months provided the symptoms abate.^10-11 During this interval, physical therapy may be employed to preserve or regain range of motion in the elbow. Clinical evidence has demonstrated improved outcomes in younger athletes with open physes.¹² Returning to athletic activities is advised only when complete resolution of symptoms has been achieved and full motion about the elbow and shoulder girdle has been regained.⁶

If symptoms persist despite nonoperative management, or if evidence of an unstable lesion (ie, detached fragment) is obtained, operative intervention is appropriate. Operative management includes diagnostic arthroscopy of the entire elbow, removal of any small, loose bodies, and synovectomy as needed. Thereafter, the OCD lesion must be addressed. In cases of capitellar OCD lesions, if the articular cartilage surface is intact, antegrade or retrograde drilling of the subchondral bone is appropriate and will likely result in a good-to-excellent functional outcome.^13-14 If disruption to the articular cartilage fissures is found or the lesion appears to be separating from the native bone, fixation of the fragment can be attempted, provided an adequate portion of the subchondral bone remains attached to the OCD lesion.^6,14 Oftentimes, the bony bed must be prepared prior to fixation by removal of any fibrous tissue overlying the subchondral bone and ensuring adequate bleeding across the entire bed. Care should be taken to remove any fibrous tissue underlying the OCD lesion. If the OCD lesion is completely loose and/or the bone stock is insufficient or fragmented, arthroscopic removal of the OCD lesion followed by débridement and abrasion arthroplasty of subchondral bone is recommended.¹⁵ Improved functional outcomes from this procedure can be expected in contained lesions.¹⁵ If the patient continues to be symptomatic, osteochondral autograft or allograft procedures can be attempted depending on the size of the remaining defect.^16-18

Other cases of radial head OCD lesions have been reported in the literature.^19-20 In 2009, Dotzis and colleagues¹⁹ reported a case of an OCD lesion that was managed nonsurgically with observation alone as the lesion was stable and non-detached. Tatebe and colleagues²⁰ reported 4 cases in which OCD involved the radial head and was accompanied by radial head subluxation. All lesions were located at the posteromedial aspect of the radial head with anterior subluxation of the radial head.²⁰ Three of the cases were managed surgically via ulnar osteotomy (2 cases) and fragment removal (1 case).²⁰ All except the 1 case treated by fragment excision revealed a good outcome.²⁰ The patient in this case presented with a detached lesion, confirmed on MRI, with pain, mechanical symptoms, and of loss of terminal extension. Given the chronicity of the injury and the presence of mechanical symptoms, the decision was made to proceed with operative intervention. During elbow arthroscopy, multiple loose bodies were removed from the elbow joint, and inspection of the radiocapitellar joint revealed extensive cartilage damage to the radial head with multiple areas of denuded cartilage and exposed bone. Since the OCD lesion was completely loose and the bone stock was insufficient and too fragmented to attempt fixation, abrasion arthroplasty was performed to stabilize the lesion and stimulate future fibrous cartilage growth. At the 6-week follow up, the patient regained full range of motion of this elbow with no complaints of pain. At the 3-month follow up, the patient reported no pain after returning to throwing and all baseball-related activities.

CONCLUSION

This report presents an extremely rare case of an OCD lesion involving the radial head. Diagnosis and treatment of this lesion followed a protocol similar to that used for the management of capitellar OCD lesions. When dealing with elbow OCD lesions, especially in the skeletally immature patient population, nonsurgical management and a gradual return to activities should be attempted. If symptoms persist despite nonoperative management or evidence of an unstable lesion (as presented in this case) is obtained, operative intervention is appropriate.

ABSTRACT

This case shows an atypical presentation of an osteochondritis dissecans (OCD) lesion of the radial head with detachment diagnosed on plain radiographs and magnetic resonance imaging (MRI). OCD lesions are rather uncommon in the elbow joint; however, when present, these lesions are typically seen in throwing athletes or gymnasts who engage in activities involving repetitive trauma to the elbow. Involvement of the radial head is extremely rare, accounting for <5% of all elbow OCD lesions. Conventional radiographs have low sensitivity for detecting OCD lesions and may frequently miss these lesions in the early stages. MRI, the imaging modality of choice, can detect these lesions at the earliest stage and provide a clear picture of the involved articular cartilage and underlying bone. Treatment options can vary between nonoperative and operative management depending on several factors, including age and activity level of the patient, size and type of lesion, and clinical presentation. This case represents a radial head OCD lesion managed by arthroscopic débridement alone, resulting in a positive outcome.

Continue to: Case Report...

CASE REPORT

A healthy, 14-year-old, left-hand-dominant adolescent boy presented to the office with a chief complaint of pain localized to the posterolateral aspect of his elbow. He described an injury where he felt a “pop” in his elbow followed by immediate pain in the posterolateral elbow after throwing a pitch during a baseball game. Since the injury, the patient had experienced difficulty extending his elbow and a sharp, throbbing pain during forearm rotation. The patient also reported an intermittent clicking feeling in the elbow. Prior to this injury, he had no elbow pain. He presented in an otherwise normal state of health with no reported past medical or surgical history and no previous trauma to the left upper extremity.

Physical examination demonstrated a mild effusion of the left elbow in the region of the posterolateral corner or “soft spot” with tenderness to palpation over the radial head. The patient had restricted elbow motion with 30° to 135° of flexion. He had 90° of pronation and supination. Ligamentous examination revealed stability of the elbow to both varus and valgus stress at 30° of flexion. No deficits were observed upon upper-extremity neurovascular examination.

Plain radiographs of the left elbow were initially taken. Anteroposterior, lateral, and Greenspan views revealed evidence of a displaced osteochondral fragment of the radial head in this skeletally immature patient. No involvement of the capitellum was apparent (Figures 1A-1C). Non-contrast magnetic resonance imaging (MRI) of the left elbow was subsequently obtained to evaluate the lesion further, and the images confirmed an unstable osteochondritis dissecans (OCD) lesion of the radial head with a detached fragment entrapped within the elbow joint (Figures 2A-2E).

Elbow arthroscopy was performed to evaluate the extent of the OCD lesion to enable determination of the integrity of the cartilaginous surface and remove the loose body entrapped within the elbow joint. Multiple loose bodies (all <5 mm in size) were removed from the elbow joint. Visualization of the radiocapitellar joint revealed extensive cartilage damage to the radial head with multiple areas of denuded cartilage and exposed bone. The main chondral defect measured approximately 4 mm in size. Probing of the lesion confirmed no stable edge; thus, abrasion arthroplasty was performed to stabilize the lesion and stimulate future fibrous cartilage growth (Figures 3A, 3B).

The patient was started on physical therapy consisting of active and active-assisted elbow ranges of motion on postoperative day 10. At the 6-week follow up, the patient presented to the office with pain-free motion of the left elbow ranging from −5° to 135° of flexion. He maintained full pronation and supination. At this point, the patient was advised to begin a throwing program. Three months after treatment, the patient resumed baseball activities, including throwing, with pain-free, full range of motion of the elbow. The patient and the patient’s parents provided written informed consent for print and electronic publication of this case report.

Continue to: Discussion...

DISCUSSION

Elbow pain is a common complaint among young baseball players. OCD lesions, however, are an uncommon entity associated with elbow pathology.¹ The overall incidence of OCD lesions is between 15 to 30 per 100,000 people.^2-3 Specifically in patients aged 2 to 19 years, the incidence of elbow OCD lesions is 2.2 per 100,000 patients and 3.8 and 0.6 per 100,000 for males and females, respectively.⁴ Radial head OCD lesions are extremely rare, occurring in <5% of all elbow OCD cases.¹ The majority of these lesions are asymptomatic and typically seen in patients who engage in repetitive overhead and upper-extremity weight-bearing activities. Reports indicate that the incidence of these lesions is on the rise and the age of presentation is decreasing, likely because of increased awareness of the disease and increasing involvement of young athletes in competitive athletics.^4-5 Most patients with elbow OCD have a history of repetitive overuse of the elbow, as seen in baseball players, leading to excessive compressive and shear forces across the radiocapitellar joint and progression of the dissecans lesion.⁶

Patients with OCD lesions of the elbow typically present with inflammatory type symptoms and lateral elbow pain. The pain tends to be mild at rest and becomes more pronounced with activity. Patients often wait until mechanical symptoms ensue (eg, clicking, catching, or locking) before presenting to the office. On physical examination, pain in the region of the OCD lesion is usually accompanied by a mild effusion. Stiffness, particularly a loss of terminal extension, may accompany the mechanical symptoms on range of motion testing.⁷

Workup of elbow OCD lesions begins with obtaining plain radiographs of the elbow. Plain films are of limited use in evaluating these lesions but can help determine separation and the approximate size of the fragment.⁸ Further work-up must include MRI sequences, which allow for the best evaluation of the articular cartilage, underlying bone, and, specifically, the size and degree of separation of the OCD lesion.⁹

Nonoperative treatment of OCD lesions is usually successful if diagnosed early. Such treatment consists of activity modification, rest, anti-inflammatory medications, and a gradual return to athletic activities over the next 3 to 6 months provided the symptoms abate.^10-11 During this interval, physical therapy may be employed to preserve or regain range of motion in the elbow. Clinical evidence has demonstrated improved outcomes in younger athletes with open physes.¹² Returning to athletic activities is advised only when complete resolution of symptoms has been achieved and full motion about the elbow and shoulder girdle has been regained.⁶

If symptoms persist despite nonoperative management, or if evidence of an unstable lesion (ie, detached fragment) is obtained, operative intervention is appropriate. Operative management includes diagnostic arthroscopy of the entire elbow, removal of any small, loose bodies, and synovectomy as needed. Thereafter, the OCD lesion must be addressed. In cases of capitellar OCD lesions, if the articular cartilage surface is intact, antegrade or retrograde drilling of the subchondral bone is appropriate and will likely result in a good-to-excellent functional outcome.^13-14 If disruption to the articular cartilage fissures is found or the lesion appears to be separating from the native bone, fixation of the fragment can be attempted, provided an adequate portion of the subchondral bone remains attached to the OCD lesion.^6,14 Oftentimes, the bony bed must be prepared prior to fixation by removal of any fibrous tissue overlying the subchondral bone and ensuring adequate bleeding across the entire bed. Care should be taken to remove any fibrous tissue underlying the OCD lesion. If the OCD lesion is completely loose and/or the bone stock is insufficient or fragmented, arthroscopic removal of the OCD lesion followed by débridement and abrasion arthroplasty of subchondral bone is recommended.¹⁵ Improved functional outcomes from this procedure can be expected in contained lesions.¹⁵ If the patient continues to be symptomatic, osteochondral autograft or allograft procedures can be attempted depending on the size of the remaining defect.^16-18

Other cases of radial head OCD lesions have been reported in the literature.^19-20 In 2009, Dotzis and colleagues¹⁹ reported a case of an OCD lesion that was managed nonsurgically with observation alone as the lesion was stable and non-detached. Tatebe and colleagues²⁰ reported 4 cases in which OCD involved the radial head and was accompanied by radial head subluxation. All lesions were located at the posteromedial aspect of the radial head with anterior subluxation of the radial head.²⁰ Three of the cases were managed surgically via ulnar osteotomy (2 cases) and fragment removal (1 case).²⁰ All except the 1 case treated by fragment excision revealed a good outcome.²⁰ The patient in this case presented with a detached lesion, confirmed on MRI, with pain, mechanical symptoms, and of loss of terminal extension. Given the chronicity of the injury and the presence of mechanical symptoms, the decision was made to proceed with operative intervention. During elbow arthroscopy, multiple loose bodies were removed from the elbow joint, and inspection of the radiocapitellar joint revealed extensive cartilage damage to the radial head with multiple areas of denuded cartilage and exposed bone. Since the OCD lesion was completely loose and the bone stock was insufficient and too fragmented to attempt fixation, abrasion arthroplasty was performed to stabilize the lesion and stimulate future fibrous cartilage growth. At the 6-week follow up, the patient regained full range of motion of this elbow with no complaints of pain. At the 3-month follow up, the patient reported no pain after returning to throwing and all baseball-related activities.

CONCLUSION

This report presents an extremely rare case of an OCD lesion involving the radial head. Diagnosis and treatment of this lesion followed a protocol similar to that used for the management of capitellar OCD lesions. When dealing with elbow OCD lesions, especially in the skeletally immature patient population, nonsurgical management and a gradual return to activities should be attempted. If symptoms persist despite nonoperative management or evidence of an unstable lesion (as presented in this case) is obtained, operative intervention is appropriate.

ABSTRACT

This case shows an atypical presentation of an osteochondritis dissecans (OCD) lesion of the radial head with detachment diagnosed on plain radiographs and magnetic resonance imaging (MRI). OCD lesions are rather uncommon in the elbow joint; however, when present, these lesions are typically seen in throwing athletes or gymnasts who engage in activities involving repetitive trauma to the elbow. Involvement of the radial head is extremely rare, accounting for <5% of all elbow OCD lesions. Conventional radiographs have low sensitivity for detecting OCD lesions and may frequently miss these lesions in the early stages. MRI, the imaging modality of choice, can detect these lesions at the earliest stage and provide a clear picture of the involved articular cartilage and underlying bone. Treatment options can vary between nonoperative and operative management depending on several factors, including age and activity level of the patient, size and type of lesion, and clinical presentation. This case represents a radial head OCD lesion managed by arthroscopic débridement alone, resulting in a positive outcome.

Continue to: Case Report...

CASE REPORT

A healthy, 14-year-old, left-hand-dominant adolescent boy presented to the office with a chief complaint of pain localized to the posterolateral aspect of his elbow. He described an injury where he felt a “pop” in his elbow followed by immediate pain in the posterolateral elbow after throwing a pitch during a baseball game. Since the injury, the patient had experienced difficulty extending his elbow and a sharp, throbbing pain during forearm rotation. The patient also reported an intermittent clicking feeling in the elbow. Prior to this injury, he had no elbow pain. He presented in an otherwise normal state of health with no reported past medical or surgical history and no previous trauma to the left upper extremity.

Physical examination demonstrated a mild effusion of the left elbow in the region of the posterolateral corner or “soft spot” with tenderness to palpation over the radial head. The patient had restricted elbow motion with 30° to 135° of flexion. He had 90° of pronation and supination. Ligamentous examination revealed stability of the elbow to both varus and valgus stress at 30° of flexion. No deficits were observed upon upper-extremity neurovascular examination.

Plain radiographs of the left elbow were initially taken. Anteroposterior, lateral, and Greenspan views revealed evidence of a displaced osteochondral fragment of the radial head in this skeletally immature patient. No involvement of the capitellum was apparent (Figures 1A-1C). Non-contrast magnetic resonance imaging (MRI) of the left elbow was subsequently obtained to evaluate the lesion further, and the images confirmed an unstable osteochondritis dissecans (OCD) lesion of the radial head with a detached fragment entrapped within the elbow joint (Figures 2A-2E).

Elbow arthroscopy was performed to evaluate the extent of the OCD lesion to enable determination of the integrity of the cartilaginous surface and remove the loose body entrapped within the elbow joint. Multiple loose bodies (all <5 mm in size) were removed from the elbow joint. Visualization of the radiocapitellar joint revealed extensive cartilage damage to the radial head with multiple areas of denuded cartilage and exposed bone. The main chondral defect measured approximately 4 mm in size. Probing of the lesion confirmed no stable edge; thus, abrasion arthroplasty was performed to stabilize the lesion and stimulate future fibrous cartilage growth (Figures 3A, 3B).

The patient was started on physical therapy consisting of active and active-assisted elbow ranges of motion on postoperative day 10. At the 6-week follow up, the patient presented to the office with pain-free motion of the left elbow ranging from −5° to 135° of flexion. He maintained full pronation and supination. At this point, the patient was advised to begin a throwing program. Three months after treatment, the patient resumed baseball activities, including throwing, with pain-free, full range of motion of the elbow. The patient and the patient’s parents provided written informed consent for print and electronic publication of this case report.

Continue to: Discussion...

DISCUSSION

Elbow pain is a common complaint among young baseball players. OCD lesions, however, are an uncommon entity associated with elbow pathology.¹ The overall incidence of OCD lesions is between 15 to 30 per 100,000 people.^2-3 Specifically in patients aged 2 to 19 years, the incidence of elbow OCD lesions is 2.2 per 100,000 patients and 3.8 and 0.6 per 100,000 for males and females, respectively.⁴ Radial head OCD lesions are extremely rare, occurring in <5% of all elbow OCD cases.¹ The majority of these lesions are asymptomatic and typically seen in patients who engage in repetitive overhead and upper-extremity weight-bearing activities. Reports indicate that the incidence of these lesions is on the rise and the age of presentation is decreasing, likely because of increased awareness of the disease and increasing involvement of young athletes in competitive athletics.^4-5 Most patients with elbow OCD have a history of repetitive overuse of the elbow, as seen in baseball players, leading to excessive compressive and shear forces across the radiocapitellar joint and progression of the dissecans lesion.⁶

Patients with OCD lesions of the elbow typically present with inflammatory type symptoms and lateral elbow pain. The pain tends to be mild at rest and becomes more pronounced with activity. Patients often wait until mechanical symptoms ensue (eg, clicking, catching, or locking) before presenting to the office. On physical examination, pain in the region of the OCD lesion is usually accompanied by a mild effusion. Stiffness, particularly a loss of terminal extension, may accompany the mechanical symptoms on range of motion testing.⁷

Workup of elbow OCD lesions begins with obtaining plain radiographs of the elbow. Plain films are of limited use in evaluating these lesions but can help determine separation and the approximate size of the fragment.⁸ Further work-up must include MRI sequences, which allow for the best evaluation of the articular cartilage, underlying bone, and, specifically, the size and degree of separation of the OCD lesion.⁹

Nonoperative treatment of OCD lesions is usually successful if diagnosed early. Such treatment consists of activity modification, rest, anti-inflammatory medications, and a gradual return to athletic activities over the next 3 to 6 months provided the symptoms abate.^10-11 During this interval, physical therapy may be employed to preserve or regain range of motion in the elbow. Clinical evidence has demonstrated improved outcomes in younger athletes with open physes.¹² Returning to athletic activities is advised only when complete resolution of symptoms has been achieved and full motion about the elbow and shoulder girdle has been regained.⁶

If symptoms persist despite nonoperative management, or if evidence of an unstable lesion (ie, detached fragment) is obtained, operative intervention is appropriate. Operative management includes diagnostic arthroscopy of the entire elbow, removal of any small, loose bodies, and synovectomy as needed. Thereafter, the OCD lesion must be addressed. In cases of capitellar OCD lesions, if the articular cartilage surface is intact, antegrade or retrograde drilling of the subchondral bone is appropriate and will likely result in a good-to-excellent functional outcome.^13-14 If disruption to the articular cartilage fissures is found or the lesion appears to be separating from the native bone, fixation of the fragment can be attempted, provided an adequate portion of the subchondral bone remains attached to the OCD lesion.^6,14 Oftentimes, the bony bed must be prepared prior to fixation by removal of any fibrous tissue overlying the subchondral bone and ensuring adequate bleeding across the entire bed. Care should be taken to remove any fibrous tissue underlying the OCD lesion. If the OCD lesion is completely loose and/or the bone stock is insufficient or fragmented, arthroscopic removal of the OCD lesion followed by débridement and abrasion arthroplasty of subchondral bone is recommended.¹⁵ Improved functional outcomes from this procedure can be expected in contained lesions.¹⁵ If the patient continues to be symptomatic, osteochondral autograft or allograft procedures can be attempted depending on the size of the remaining defect.^16-18

Other cases of radial head OCD lesions have been reported in the literature.^19-20 In 2009, Dotzis and colleagues¹⁹ reported a case of an OCD lesion that was managed nonsurgically with observation alone as the lesion was stable and non-detached. Tatebe and colleagues²⁰ reported 4 cases in which OCD involved the radial head and was accompanied by radial head subluxation. All lesions were located at the posteromedial aspect of the radial head with anterior subluxation of the radial head.²⁰ Three of the cases were managed surgically via ulnar osteotomy (2 cases) and fragment removal (1 case).²⁰ All except the 1 case treated by fragment excision revealed a good outcome.²⁰ The patient in this case presented with a detached lesion, confirmed on MRI, with pain, mechanical symptoms, and of loss of terminal extension. Given the chronicity of the injury and the presence of mechanical symptoms, the decision was made to proceed with operative intervention. During elbow arthroscopy, multiple loose bodies were removed from the elbow joint, and inspection of the radiocapitellar joint revealed extensive cartilage damage to the radial head with multiple areas of denuded cartilage and exposed bone. Since the OCD lesion was completely loose and the bone stock was insufficient and too fragmented to attempt fixation, abrasion arthroplasty was performed to stabilize the lesion and stimulate future fibrous cartilage growth. At the 6-week follow up, the patient regained full range of motion of this elbow with no complaints of pain. At the 3-month follow up, the patient reported no pain after returning to throwing and all baseball-related activities.

CONCLUSION

This report presents an extremely rare case of an OCD lesion involving the radial head. Diagnosis and treatment of this lesion followed a protocol similar to that used for the management of capitellar OCD lesions. When dealing with elbow OCD lesions, especially in the skeletally immature patient population, nonsurgical management and a gradual return to activities should be attempted. If symptoms persist despite nonoperative management or evidence of an unstable lesion (as presented in this case) is obtained, operative intervention is appropriate.

ABSTRACT

Fiberglass casts are frequently valved to accommodate swelling following injury or surgery. The use of cast spacers has been recommended to bridge this gap between pressure reduction and cast strength, but no studies have assessed their effect on cast pressure.

We applied 30 long-arm fiberglass casts to adult volunteers, divided between a univalve group and a bivalve group. A pediatric blood pressure bladder was applied under the cast to simulate soft tissue swelling. Valved casts were secured using an elastic wrap, 10-mm cast spacer, or 15-mm cast spacer. Measurements of cast pressure and circumference were performed at each stage and compared on the basis of type of valve and securement.

Our results indicated that cast univalving resulted in an approximately 60% reduction in cast pressures, with a 75% reduction seen in the bivalve group. The addition of cast spacers resulted in significant pressure reductions for both valving groups. The univalve group secured with a 10-mm cast spacer produced reductions in cast pressure similar to those of the elastic-wrapped bivalve cast, both with the cast padding intact and with it released.

The use of cast spacers results in significant cast pressure reductions, regardless of valving technique. A univalved cast secured with a cast spacer can produce decreases in cast pressures similar to those seen with an elastic-wrapped bivalved cast, and it is a viable option for reducing cast pressure without compromising cast structural integrity with a bivalve technique.

Continue to: Complications following closed reduction...

Complications following closed reduction and casting of pediatric forearm fractures are rare, but they do occur. Arguably the most devastating of these complications is the risk of developing compartment syndrome or Volkmann contracture secondary to injury-associated swelling under a circumferential cast.^1-4 The peak in swelling can develop from 4 to 24 hours following the initial cast application,⁵ and as such, medical providers may not be able to identify it early because most children are discharged following closed reductions. For this reason, many providers implement prophylactic measures to minimize pressure-related complications.

A popular method for reducing pressure accumulation within a cast is to valve, or cut, the cast. Previous investigations have shown that cast valving results in significant reductions in cast pressure.^2,6-9 Bivalving a circumferential cast results in significantly greater reductions in cast pressure when compared with univalve techniques;^6,7,9 however, bivalving has also been shown to result in significant impairment in the structural integrity of the cast.¹⁰ An additional method to facilitate cast pressure reduction without impairing the structural integrity of the cast that accompanies a bivalve is to incorporate a cast spacer with a univalve technique to hold the split cast open.¹¹ Although this method is commonly used in clinical practice, its ability to mitigate cast pressures has not previously been investigated.

The goal of this study is to investigate the influence of incorporating cast spacers with valved long-arm casts. We hypothesized that cast spacers would provide a greater pressure reduction for both univalved and bivalved casts when compared with the use of an elastic wrap. Additionally, we proposed that by incorporating a cast spacer with a univalved cast, we could attain pressure reduction equivalent to that of a bivalved cast secured with an elastic wrap.

MATERIALS AND METHODS

Upon receiving approval from the Institutional Review Board, experimental testing began with the application of 30 total casts performed on uninjured adult human volunteers. Pressure readings were provided with the use of a bladder from a pediatric blood pressure cuff (Welch Allyn Inc), as previously described.⁶ The bladder was placed on the volar aspect of the volunteer’s forearm, held in place with a 3-in diameter cotton stockinet (3M). Cotton cast padding (Webril-Kendall) was applied, 3 in wide and 2 layers thick, and a long-arm cast was applied, 2 layers thick with 3-in wide fiberglass casting material (Scotchcast Plus Casting Tape; 3M).

Once the cast was applied and allowed to set, the blood pressure bladder was inflated to 100 mm Hg. After inflation, forearm cast circumference was measured at 2 set points, assessed at points 2 cm distal to the elbow flexor crease and 10 cm distal to the previous point (Figure 1). Using these data, we calculated estimated cast volume using the volumetric equation for a frustum. Following this point, casts were split into 2 experimental groups, univalve or bivalve, with 15 casts comprising each group. The univalve group consisted of a single cut along the dorsum of the extremity, and the bivalve group incorporated a second cut to the volar extremity. Cast valving was performed using an oscillating cast saw (Cast Vac; Stryker Instruments), with care taken to ensure the continuity of the underlying cast padding.

Continue to: Following valving, casts were secured via...

Following valving, casts were secured via 3 separate techniques: overwrap with a 3-in elastic wrap (Econo Wrap; Vitality Medical), application of two 10-mm and 15-mm cast spacers (CastWedge; DM Systems) (Figure 2). After securement, cast pressures were recorded, and circumference measurements were performed at the 2 previously identified points. The cast padding was then cut at the valve site and secured via the 3 listed techniques. Cast pressure and circumference measurements were performed at set time points (Figure 3). Changes in cast pressure were recorded in terms of the amount of change from the initial cast placement to account for differences in the size of volunteers’ forearms. Volumetric calculations were performed only for the spacer subgroups owing to the added material in the elastic wrap group. Estimated cast volume was calculated using the equation for volume of a frustum (Figure 4).

We used a 2-cast type (univalve and bivalve) by 4 securement subgroups (initial, elastic wrap, 10-mm spacer, and 15-mm spacer) design, with cast type serving as a between-subject measure and securement serving as a within-subject variable. An a priori power analysis showed that a minimum sample size of 15 subjects per condition should provide sufficient power of .80 and alpha set at .05, for a total of 30 casts. Statistical analyses were performed using IBM SPSS Statistics software version 21 (IBM). Experimental groups were analyzed using mixed-design analysis of variance (ANOVA). Post hoc comparisons between valving groups and cast securement were performed using Scheffe’s test to control for type II errors. Change in cast volume between the initial cast and cast spacers groups was compared using paired Student’s t tests. Statistical significance was predetermined as P < .05.

RESULTS

A summary of collected data for cast pressure and volume is detailed in Table 1, subdividing the variables on the basis of cast type and type of securement. Recorded pressures of the different subgroups are depicted in Figures 5 and 6 according to type of securement (initial, elastic wrap, 10-mm spacer, or 15-mm spacer). Results of the mixed-design ANOVA demonstrated significant differences between the initial cast pressure and univalve and bivalve groups (P < .05). There was a main effect for bivalve having lower pressure overall (F [1, 1)] = 3321.51, P < .001). There was also a main effect indicating that pressure was different for each type of securement (elastic wrap, 10-mm spacer, 15-mm spacer) (F [1, 28] = 538.54, P <. 01). Post hoc testing confirmed pressure decreased significantly, in descending order from elastic wrap, to 10-mm spacers, to 15-mm spacers (P < .05).

Table 1. Cumulative Data for Two Casting groups at Each Timepoint

Continue to: Table 2...

The summary of volumetric changes is listed in Table 2. The decrease in pressure correlated with an associated increase in cast volume, as demonstrated in Figure 7. The degree of increase in cast volume was more pronounced in the bivalve group (P < .001). The volume increased in the 15-mm group compared with the 10-mm group for both groups (P < .001) and increased for each spacer group with the release of the underlying padding (P < .05).

Table 2. Volumetric Data

Analysis of the planned comparisons demonstrated no significant difference between the bivalve with elastic wrap and univalve with 10-mm spacer subgroups (t [28] = 1.85, P = .075, d = .68). In comparing the bivalve with elastic wrap group with the univalve and 15-mm spacer subgroup, the univalve group showed significantly lower pressures [t [28] = 6.32, P < .001, d = .2.31).

DISCUSSION

Valving of circumferential casting is a well-established technique to minimize potential pressure-related complications. Previous studies have demonstrated that univalving techniques produce a 65% reduction in cast pressure, whereas bivalving produces an 80% decrease.^6,7,9 Our results showed comparable pressure reductions of 75% with bivalving and 60% with univalving. The type of cast padding has been shown to have a significant effect on the cast pressure, favoring lower pressures with cotton padding over synthetic and waterproof padding, which, when released, can provide an additional 10% pressure reduction.^6,7

Although bivalving techniques are superior in pressure reduction, the reduction comes at the cost of the cast’s structural integrity. Crickard and colleagues¹⁰ performed a biomechanical assessment of the structural integrity by 3-point bending of casts following univalve and bivalve compared with an intact cast. The authors found that valving resulted in a significant decrease in the casts’ bending stiffness and load to failure, with bivalved casts demonstrating a significantly lower load to failure than univalved casts. One technique that has been used to enhance the pressure reduction in univalved casting techniques is the application of a cast spacer. Rang and colleagues¹¹ recommended this technique as part of a graded cast-splitting approach for the treatment of children’s fractures. This technique was applied to fractures with only modest anticipated swelling, which accounted for approximately 95% of casts applied in their children’s hospital. Our results support the use of cast spacers, demonstrating significant reduction in cast pressure in both univalve and bivalve techniques. Additionally, we found that a univalved cast with a 10-mm cast spacer provided pressure reduction similar to that of a bivalved cast.

The theory behind the application of cast spacers is that a split fiberglass cast will not remain open unless held in position.¹¹ Holding the cast open is less of a restraint to pressure reduction in bivalving techniques, because the split cast no longer has the contralateral intact hinge point to resist cast opening, demonstrated in the compromise in structural integrity seen with this technique.¹⁰ By maintaining the split cast in an opened position, the effective volume of the cast is increased, which allows for the reduction in cast pressure. This is demonstrated in our results indicating an increase in estimated cast volume with an associated incremental reduction in cast pressure with the application of incrementally sized cast spacers. Although this technique does have the potential for skin irritation caused by cast expansion, as well as local swelling at the cast window location, it is a cost-effective treatment method compared with overwrapping a bivalved cast, $1.55 for 1 cast spacer vs an estimated $200 for a forearm cast application.

This study is not without its limitations. Our model does not account for the soft tissue injury associated with forearm fractures. However, by using human volunteers, we were able to include the viscoelastic properties that are omitted with nonliving models, and our results do align with those of previous investigations regarding pressure change following valving. We did not incorporate a 3-point molding technique commonly used with reduction and casting of acute forearm fractures, owing to the lack of a standardized method for applying the mold to healthy volunteers. Although molding is necessary for most fractures in which valving is considered, we believe our data still provide valuable information. Additionally, valving of circumferential casts has not been shown, prospectively, to result in a reduction of cast-related compartment syndrome, maintenance of reduction, or need for surgery.^12,13 However, these results are reflective of reliable patients who completed the requisite follow-up care necessary for inclusion in a randomized controlled trial and may be applicable to unreliable patients or patient situations, a setting in which the compromise in cast structural integrity may be unacceptable.

CONCLUSION

We demonstrated that incorporating cast spacers into valved long-arm casts provides pressure reduction comparable to that achieved with the use of an elastic wrap. The addition of a 10-mm cast spacer to a univalved long-arm cast provides pressure reduction equivalent to that of a bivalved cast secured with an elastic wrap. A univalved cast secured with a cast spacer is a viable option for treatment of displaced pediatric forearm fractures, without compromising the cast’s structural integrity as required with bivalved techniques.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Fiberglass casts are frequently valved to accommodate swelling following injury or surgery. The use of cast spacers has been recommended to bridge this gap between pressure reduction and cast strength, but no studies have assessed their effect on cast pressure.

We applied 30 long-arm fiberglass casts to adult volunteers, divided between a univalve group and a bivalve group. A pediatric blood pressure bladder was applied under the cast to simulate soft tissue swelling. Valved casts were secured using an elastic wrap, 10-mm cast spacer, or 15-mm cast spacer. Measurements of cast pressure and circumference were performed at each stage and compared on the basis of type of valve and securement.

Our results indicated that cast univalving resulted in an approximately 60% reduction in cast pressures, with a 75% reduction seen in the bivalve group. The addition of cast spacers resulted in significant pressure reductions for both valving groups. The univalve group secured with a 10-mm cast spacer produced reductions in cast pressure similar to those of the elastic-wrapped bivalve cast, both with the cast padding intact and with it released.

The use of cast spacers results in significant cast pressure reductions, regardless of valving technique. A univalved cast secured with a cast spacer can produce decreases in cast pressures similar to those seen with an elastic-wrapped bivalved cast, and it is a viable option for reducing cast pressure without compromising cast structural integrity with a bivalve technique.

Continue to: Complications following closed reduction...

Complications following closed reduction and casting of pediatric forearm fractures are rare, but they do occur. Arguably the most devastating of these complications is the risk of developing compartment syndrome or Volkmann contracture secondary to injury-associated swelling under a circumferential cast.^1-4 The peak in swelling can develop from 4 to 24 hours following the initial cast application,⁵ and as such, medical providers may not be able to identify it early because most children are discharged following closed reductions. For this reason, many providers implement prophylactic measures to minimize pressure-related complications.

A popular method for reducing pressure accumulation within a cast is to valve, or cut, the cast. Previous investigations have shown that cast valving results in significant reductions in cast pressure.^2,6-9 Bivalving a circumferential cast results in significantly greater reductions in cast pressure when compared with univalve techniques;^6,7,9 however, bivalving has also been shown to result in significant impairment in the structural integrity of the cast.¹⁰ An additional method to facilitate cast pressure reduction without impairing the structural integrity of the cast that accompanies a bivalve is to incorporate a cast spacer with a univalve technique to hold the split cast open.¹¹ Although this method is commonly used in clinical practice, its ability to mitigate cast pressures has not previously been investigated.

The goal of this study is to investigate the influence of incorporating cast spacers with valved long-arm casts. We hypothesized that cast spacers would provide a greater pressure reduction for both univalved and bivalved casts when compared with the use of an elastic wrap. Additionally, we proposed that by incorporating a cast spacer with a univalved cast, we could attain pressure reduction equivalent to that of a bivalved cast secured with an elastic wrap.

MATERIALS AND METHODS

Upon receiving approval from the Institutional Review Board, experimental testing began with the application of 30 total casts performed on uninjured adult human volunteers. Pressure readings were provided with the use of a bladder from a pediatric blood pressure cuff (Welch Allyn Inc), as previously described.⁶ The bladder was placed on the volar aspect of the volunteer’s forearm, held in place with a 3-in diameter cotton stockinet (3M). Cotton cast padding (Webril-Kendall) was applied, 3 in wide and 2 layers thick, and a long-arm cast was applied, 2 layers thick with 3-in wide fiberglass casting material (Scotchcast Plus Casting Tape; 3M).

Once the cast was applied and allowed to set, the blood pressure bladder was inflated to 100 mm Hg. After inflation, forearm cast circumference was measured at 2 set points, assessed at points 2 cm distal to the elbow flexor crease and 10 cm distal to the previous point (Figure 1). Using these data, we calculated estimated cast volume using the volumetric equation for a frustum. Following this point, casts were split into 2 experimental groups, univalve or bivalve, with 15 casts comprising each group. The univalve group consisted of a single cut along the dorsum of the extremity, and the bivalve group incorporated a second cut to the volar extremity. Cast valving was performed using an oscillating cast saw (Cast Vac; Stryker Instruments), with care taken to ensure the continuity of the underlying cast padding.

Continue to: Following valving, casts were secured via...

Following valving, casts were secured via 3 separate techniques: overwrap with a 3-in elastic wrap (Econo Wrap; Vitality Medical), application of two 10-mm and 15-mm cast spacers (CastWedge; DM Systems) (Figure 2). After securement, cast pressures were recorded, and circumference measurements were performed at the 2 previously identified points. The cast padding was then cut at the valve site and secured via the 3 listed techniques. Cast pressure and circumference measurements were performed at set time points (Figure 3). Changes in cast pressure were recorded in terms of the amount of change from the initial cast placement to account for differences in the size of volunteers’ forearms. Volumetric calculations were performed only for the spacer subgroups owing to the added material in the elastic wrap group. Estimated cast volume was calculated using the equation for volume of a frustum (Figure 4).

We used a 2-cast type (univalve and bivalve) by 4 securement subgroups (initial, elastic wrap, 10-mm spacer, and 15-mm spacer) design, with cast type serving as a between-subject measure and securement serving as a within-subject variable. An a priori power analysis showed that a minimum sample size of 15 subjects per condition should provide sufficient power of .80 and alpha set at .05, for a total of 30 casts. Statistical analyses were performed using IBM SPSS Statistics software version 21 (IBM). Experimental groups were analyzed using mixed-design analysis of variance (ANOVA). Post hoc comparisons between valving groups and cast securement were performed using Scheffe’s test to control for type II errors. Change in cast volume between the initial cast and cast spacers groups was compared using paired Student’s t tests. Statistical significance was predetermined as P < .05.

RESULTS

A summary of collected data for cast pressure and volume is detailed in Table 1, subdividing the variables on the basis of cast type and type of securement. Recorded pressures of the different subgroups are depicted in Figures 5 and 6 according to type of securement (initial, elastic wrap, 10-mm spacer, or 15-mm spacer). Results of the mixed-design ANOVA demonstrated significant differences between the initial cast pressure and univalve and bivalve groups (P < .05). There was a main effect for bivalve having lower pressure overall (F [1, 1)] = 3321.51, P < .001). There was also a main effect indicating that pressure was different for each type of securement (elastic wrap, 10-mm spacer, 15-mm spacer) (F [1, 28] = 538.54, P <. 01). Post hoc testing confirmed pressure decreased significantly, in descending order from elastic wrap, to 10-mm spacers, to 15-mm spacers (P < .05).

Table 1. Cumulative Data for Two Casting groups at Each Timepoint

Continue to: Table 2...

The summary of volumetric changes is listed in Table 2. The decrease in pressure correlated with an associated increase in cast volume, as demonstrated in Figure 7. The degree of increase in cast volume was more pronounced in the bivalve group (P < .001). The volume increased in the 15-mm group compared with the 10-mm group for both groups (P < .001) and increased for each spacer group with the release of the underlying padding (P < .05).

Table 2. Volumetric Data

Analysis of the planned comparisons demonstrated no significant difference between the bivalve with elastic wrap and univalve with 10-mm spacer subgroups (t [28] = 1.85, P = .075, d = .68). In comparing the bivalve with elastic wrap group with the univalve and 15-mm spacer subgroup, the univalve group showed significantly lower pressures [t [28] = 6.32, P < .001, d = .2.31).

DISCUSSION

Valving of circumferential casting is a well-established technique to minimize potential pressure-related complications. Previous studies have demonstrated that univalving techniques produce a 65% reduction in cast pressure, whereas bivalving produces an 80% decrease.^6,7,9 Our results showed comparable pressure reductions of 75% with bivalving and 60% with univalving. The type of cast padding has been shown to have a significant effect on the cast pressure, favoring lower pressures with cotton padding over synthetic and waterproof padding, which, when released, can provide an additional 10% pressure reduction.^6,7

Although bivalving techniques are superior in pressure reduction, the reduction comes at the cost of the cast’s structural integrity. Crickard and colleagues¹⁰ performed a biomechanical assessment of the structural integrity by 3-point bending of casts following univalve and bivalve compared with an intact cast. The authors found that valving resulted in a significant decrease in the casts’ bending stiffness and load to failure, with bivalved casts demonstrating a significantly lower load to failure than univalved casts. One technique that has been used to enhance the pressure reduction in univalved casting techniques is the application of a cast spacer. Rang and colleagues¹¹ recommended this technique as part of a graded cast-splitting approach for the treatment of children’s fractures. This technique was applied to fractures with only modest anticipated swelling, which accounted for approximately 95% of casts applied in their children’s hospital. Our results support the use of cast spacers, demonstrating significant reduction in cast pressure in both univalve and bivalve techniques. Additionally, we found that a univalved cast with a 10-mm cast spacer provided pressure reduction similar to that of a bivalved cast.

The theory behind the application of cast spacers is that a split fiberglass cast will not remain open unless held in position.¹¹ Holding the cast open is less of a restraint to pressure reduction in bivalving techniques, because the split cast no longer has the contralateral intact hinge point to resist cast opening, demonstrated in the compromise in structural integrity seen with this technique.¹⁰ By maintaining the split cast in an opened position, the effective volume of the cast is increased, which allows for the reduction in cast pressure. This is demonstrated in our results indicating an increase in estimated cast volume with an associated incremental reduction in cast pressure with the application of incrementally sized cast spacers. Although this technique does have the potential for skin irritation caused by cast expansion, as well as local swelling at the cast window location, it is a cost-effective treatment method compared with overwrapping a bivalved cast, $1.55 for 1 cast spacer vs an estimated $200 for a forearm cast application.

This study is not without its limitations. Our model does not account for the soft tissue injury associated with forearm fractures. However, by using human volunteers, we were able to include the viscoelastic properties that are omitted with nonliving models, and our results do align with those of previous investigations regarding pressure change following valving. We did not incorporate a 3-point molding technique commonly used with reduction and casting of acute forearm fractures, owing to the lack of a standardized method for applying the mold to healthy volunteers. Although molding is necessary for most fractures in which valving is considered, we believe our data still provide valuable information. Additionally, valving of circumferential casts has not been shown, prospectively, to result in a reduction of cast-related compartment syndrome, maintenance of reduction, or need for surgery.^12,13 However, these results are reflective of reliable patients who completed the requisite follow-up care necessary for inclusion in a randomized controlled trial and may be applicable to unreliable patients or patient situations, a setting in which the compromise in cast structural integrity may be unacceptable.

CONCLUSION

We demonstrated that incorporating cast spacers into valved long-arm casts provides pressure reduction comparable to that achieved with the use of an elastic wrap. The addition of a 10-mm cast spacer to a univalved long-arm cast provides pressure reduction equivalent to that of a bivalved cast secured with an elastic wrap. A univalved cast secured with a cast spacer is a viable option for treatment of displaced pediatric forearm fractures, without compromising the cast’s structural integrity as required with bivalved techniques.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Fiberglass casts are frequently valved to accommodate swelling following injury or surgery. The use of cast spacers has been recommended to bridge this gap between pressure reduction and cast strength, but no studies have assessed their effect on cast pressure.

We applied 30 long-arm fiberglass casts to adult volunteers, divided between a univalve group and a bivalve group. A pediatric blood pressure bladder was applied under the cast to simulate soft tissue swelling. Valved casts were secured using an elastic wrap, 10-mm cast spacer, or 15-mm cast spacer. Measurements of cast pressure and circumference were performed at each stage and compared on the basis of type of valve and securement.

Our results indicated that cast univalving resulted in an approximately 60% reduction in cast pressures, with a 75% reduction seen in the bivalve group. The addition of cast spacers resulted in significant pressure reductions for both valving groups. The univalve group secured with a 10-mm cast spacer produced reductions in cast pressure similar to those of the elastic-wrapped bivalve cast, both with the cast padding intact and with it released.

The use of cast spacers results in significant cast pressure reductions, regardless of valving technique. A univalved cast secured with a cast spacer can produce decreases in cast pressures similar to those seen with an elastic-wrapped bivalved cast, and it is a viable option for reducing cast pressure without compromising cast structural integrity with a bivalve technique.

Continue to: Complications following closed reduction...

Complications following closed reduction and casting of pediatric forearm fractures are rare, but they do occur. Arguably the most devastating of these complications is the risk of developing compartment syndrome or Volkmann contracture secondary to injury-associated swelling under a circumferential cast.^1-4 The peak in swelling can develop from 4 to 24 hours following the initial cast application,⁵ and as such, medical providers may not be able to identify it early because most children are discharged following closed reductions. For this reason, many providers implement prophylactic measures to minimize pressure-related complications.

A popular method for reducing pressure accumulation within a cast is to valve, or cut, the cast. Previous investigations have shown that cast valving results in significant reductions in cast pressure.^2,6-9 Bivalving a circumferential cast results in significantly greater reductions in cast pressure when compared with univalve techniques;^6,7,9 however, bivalving has also been shown to result in significant impairment in the structural integrity of the cast.¹⁰ An additional method to facilitate cast pressure reduction without impairing the structural integrity of the cast that accompanies a bivalve is to incorporate a cast spacer with a univalve technique to hold the split cast open.¹¹ Although this method is commonly used in clinical practice, its ability to mitigate cast pressures has not previously been investigated.

The goal of this study is to investigate the influence of incorporating cast spacers with valved long-arm casts. We hypothesized that cast spacers would provide a greater pressure reduction for both univalved and bivalved casts when compared with the use of an elastic wrap. Additionally, we proposed that by incorporating a cast spacer with a univalved cast, we could attain pressure reduction equivalent to that of a bivalved cast secured with an elastic wrap.

MATERIALS AND METHODS

Upon receiving approval from the Institutional Review Board, experimental testing began with the application of 30 total casts performed on uninjured adult human volunteers. Pressure readings were provided with the use of a bladder from a pediatric blood pressure cuff (Welch Allyn Inc), as previously described.⁶ The bladder was placed on the volar aspect of the volunteer’s forearm, held in place with a 3-in diameter cotton stockinet (3M). Cotton cast padding (Webril-Kendall) was applied, 3 in wide and 2 layers thick, and a long-arm cast was applied, 2 layers thick with 3-in wide fiberglass casting material (Scotchcast Plus Casting Tape; 3M).

Once the cast was applied and allowed to set, the blood pressure bladder was inflated to 100 mm Hg. After inflation, forearm cast circumference was measured at 2 set points, assessed at points 2 cm distal to the elbow flexor crease and 10 cm distal to the previous point (Figure 1). Using these data, we calculated estimated cast volume using the volumetric equation for a frustum. Following this point, casts were split into 2 experimental groups, univalve or bivalve, with 15 casts comprising each group. The univalve group consisted of a single cut along the dorsum of the extremity, and the bivalve group incorporated a second cut to the volar extremity. Cast valving was performed using an oscillating cast saw (Cast Vac; Stryker Instruments), with care taken to ensure the continuity of the underlying cast padding.

Continue to: Following valving, casts were secured via...

Following valving, casts were secured via 3 separate techniques: overwrap with a 3-in elastic wrap (Econo Wrap; Vitality Medical), application of two 10-mm and 15-mm cast spacers (CastWedge; DM Systems) (Figure 2). After securement, cast pressures were recorded, and circumference measurements were performed at the 2 previously identified points. The cast padding was then cut at the valve site and secured via the 3 listed techniques. Cast pressure and circumference measurements were performed at set time points (Figure 3). Changes in cast pressure were recorded in terms of the amount of change from the initial cast placement to account for differences in the size of volunteers’ forearms. Volumetric calculations were performed only for the spacer subgroups owing to the added material in the elastic wrap group. Estimated cast volume was calculated using the equation for volume of a frustum (Figure 4).

We used a 2-cast type (univalve and bivalve) by 4 securement subgroups (initial, elastic wrap, 10-mm spacer, and 15-mm spacer) design, with cast type serving as a between-subject measure and securement serving as a within-subject variable. An a priori power analysis showed that a minimum sample size of 15 subjects per condition should provide sufficient power of .80 and alpha set at .05, for a total of 30 casts. Statistical analyses were performed using IBM SPSS Statistics software version 21 (IBM). Experimental groups were analyzed using mixed-design analysis of variance (ANOVA). Post hoc comparisons between valving groups and cast securement were performed using Scheffe’s test to control for type II errors. Change in cast volume between the initial cast and cast spacers groups was compared using paired Student’s t tests. Statistical significance was predetermined as P < .05.

RESULTS

A summary of collected data for cast pressure and volume is detailed in Table 1, subdividing the variables on the basis of cast type and type of securement. Recorded pressures of the different subgroups are depicted in Figures 5 and 6 according to type of securement (initial, elastic wrap, 10-mm spacer, or 15-mm spacer). Results of the mixed-design ANOVA demonstrated significant differences between the initial cast pressure and univalve and bivalve groups (P < .05). There was a main effect for bivalve having lower pressure overall (F [1, 1)] = 3321.51, P < .001). There was also a main effect indicating that pressure was different for each type of securement (elastic wrap, 10-mm spacer, 15-mm spacer) (F [1, 28] = 538.54, P <. 01). Post hoc testing confirmed pressure decreased significantly, in descending order from elastic wrap, to 10-mm spacers, to 15-mm spacers (P < .05).

Table 1. Cumulative Data for Two Casting groups at Each Timepoint

Continue to: Table 2...

The summary of volumetric changes is listed in Table 2. The decrease in pressure correlated with an associated increase in cast volume, as demonstrated in Figure 7. The degree of increase in cast volume was more pronounced in the bivalve group (P < .001). The volume increased in the 15-mm group compared with the 10-mm group for both groups (P < .001) and increased for each spacer group with the release of the underlying padding (P < .05).

Table 2. Volumetric Data

Analysis of the planned comparisons demonstrated no significant difference between the bivalve with elastic wrap and univalve with 10-mm spacer subgroups (t [28] = 1.85, P = .075, d = .68). In comparing the bivalve with elastic wrap group with the univalve and 15-mm spacer subgroup, the univalve group showed significantly lower pressures [t [28] = 6.32, P < .001, d = .2.31).

DISCUSSION

Valving of circumferential casting is a well-established technique to minimize potential pressure-related complications. Previous studies have demonstrated that univalving techniques produce a 65% reduction in cast pressure, whereas bivalving produces an 80% decrease.^6,7,9 Our results showed comparable pressure reductions of 75% with bivalving and 60% with univalving. The type of cast padding has been shown to have a significant effect on the cast pressure, favoring lower pressures with cotton padding over synthetic and waterproof padding, which, when released, can provide an additional 10% pressure reduction.^6,7

Although bivalving techniques are superior in pressure reduction, the reduction comes at the cost of the cast’s structural integrity. Crickard and colleagues¹⁰ performed a biomechanical assessment of the structural integrity by 3-point bending of casts following univalve and bivalve compared with an intact cast. The authors found that valving resulted in a significant decrease in the casts’ bending stiffness and load to failure, with bivalved casts demonstrating a significantly lower load to failure than univalved casts. One technique that has been used to enhance the pressure reduction in univalved casting techniques is the application of a cast spacer. Rang and colleagues¹¹ recommended this technique as part of a graded cast-splitting approach for the treatment of children’s fractures. This technique was applied to fractures with only modest anticipated swelling, which accounted for approximately 95% of casts applied in their children’s hospital. Our results support the use of cast spacers, demonstrating significant reduction in cast pressure in both univalve and bivalve techniques. Additionally, we found that a univalved cast with a 10-mm cast spacer provided pressure reduction similar to that of a bivalved cast.

The theory behind the application of cast spacers is that a split fiberglass cast will not remain open unless held in position.¹¹ Holding the cast open is less of a restraint to pressure reduction in bivalving techniques, because the split cast no longer has the contralateral intact hinge point to resist cast opening, demonstrated in the compromise in structural integrity seen with this technique.¹⁰ By maintaining the split cast in an opened position, the effective volume of the cast is increased, which allows for the reduction in cast pressure. This is demonstrated in our results indicating an increase in estimated cast volume with an associated incremental reduction in cast pressure with the application of incrementally sized cast spacers. Although this technique does have the potential for skin irritation caused by cast expansion, as well as local swelling at the cast window location, it is a cost-effective treatment method compared with overwrapping a bivalved cast, $1.55 for 1 cast spacer vs an estimated $200 for a forearm cast application.

This study is not without its limitations. Our model does not account for the soft tissue injury associated with forearm fractures. However, by using human volunteers, we were able to include the viscoelastic properties that are omitted with nonliving models, and our results do align with those of previous investigations regarding pressure change following valving. We did not incorporate a 3-point molding technique commonly used with reduction and casting of acute forearm fractures, owing to the lack of a standardized method for applying the mold to healthy volunteers. Although molding is necessary for most fractures in which valving is considered, we believe our data still provide valuable information. Additionally, valving of circumferential casts has not been shown, prospectively, to result in a reduction of cast-related compartment syndrome, maintenance of reduction, or need for surgery.^12,13 However, these results are reflective of reliable patients who completed the requisite follow-up care necessary for inclusion in a randomized controlled trial and may be applicable to unreliable patients or patient situations, a setting in which the compromise in cast structural integrity may be unacceptable.

CONCLUSION

We demonstrated that incorporating cast spacers into valved long-arm casts provides pressure reduction comparable to that achieved with the use of an elastic wrap. The addition of a 10-mm cast spacer to a univalved long-arm cast provides pressure reduction equivalent to that of a bivalved cast secured with an elastic wrap. A univalved cast secured with a cast spacer is a viable option for treatment of displaced pediatric forearm fractures, without compromising the cast’s structural integrity as required with bivalved techniques.

This paper will be judged for the Resident Writer’s Award.

By 2025, it is estimated that the annual cost of treating osteoporosis-related fractures in the United States will be 25 billion dollars, which is 10 billion dollars more than was spent in 2010.¹ As healthcare costs in the United States continue to skyrocket, it is imperative that orthopedic surgeons take an active role in avoiding preventable injury and disease. For orthopedic surgeons, preventative medicine will include promoting bone health and educating patients on injury prevention. By incorporating these principles into residency and fellowship education, and by leveraging the electronic medical record to support preventive care through systematic reminders, orthopedic surgeons have a critical opportunity to take a leading role in promoting prevention to our patients.

In 2009, the American Orthopaedic Association (AOA) launched a “Own the Bone” campaign, a national quality improvement program designed to optimize the treatment of osteoporosis.² This program came about following the Surgeon General’s call, in 2004, for orthopedic surgeons to take a more active role in treating osteoporosis. The program primarily aims to improve treatment of osteoporosis after a fragility fracture in an inpatient setting. Early results from a 2010 follow-up study showed that the new emphasis on prevention inspired by this program is effective. As compared with patients who had osteoporosis work-up and treatment initiated during their hospital admission, the group of patients who were referred for osteoporosis treatment after discharge were found to have a significantly lower rate of diagnosis and treatment.³ The loss of aftercare for patients who do not obtain immediate diagnosis and treatment for osteoporosis can and should be avoided. Many hospitals now have hip fracture services with multidisciplinary input. The successful outcomes of these programs include shorter times to the operating room, shorter hospital stays, decreased readmission, and decreased 30-day mortality.^4-6 These services provide an excellent opportunity to ensure that each patient has initiated management of osteoporosis before discharge. Ideally, patients would be scheduled for bone mineral density testing prior to leaving the hospital, when applicable, and would begin calcium and vitamin D supplementation or bisphosphonate treatment in the hospital, when appropriate. As part of these hip fracture services, a goal of clearly initiating or managing treatment for osteoporosis should be routinely addressed.

While patients presenting with hip fractures are an easily identifiable high-risk population, other patients present in an outpatient setting following fragility fractures, such as distal radius or vertebral compression fractures. These patients should be considered for osteoporosis work-up and counseled accordingly. A recent study compared the efficacy of the orthopedic surgeon initiating bone mineral density testing after a distal radius fracture, compared with referring the patient back to their primary care physician for testing. The study found a significantly higher rate of patients going on to bone mineral density testing when the surgeon initiated this process.⁷ In the era of improved digital communication, the outpatient setting offers an opportunity for clinicians to communicate with patients’ primary care physicians and initiate a multidisciplinary approach to bone health and prevention. In the outpatient setting, the orthopedist can address nutritional issues and screening on a repeated basis. Studies have demonstrated that physician counseling can be very effective in changing behavior and helping patients to stop using tobacco.⁸ In this vein, efforts by the physician to encourage calcium and vitamin D intake and weight-bearing exercise have the potential to be very effective.

Programs such as “Own the Bone” are crucial to orthopedists’ treatment of osteoporosis, but prevention of bone disease and fragility fracture must extend even further. Individual practitioners must be cognizant that many patients may benefit from outpatient diagnosis of osteoporosis and initiation of appropriate treatment, before fragility fractures occur. Moreover, although patients at high risk include post-menopausal women, orthopedists need to be consistently aware of osteoporosis as a disease of both genders. An estimated 2.8 million men in the United States have osteoporosis.⁹ A 2012 study published out of Washington, DC found a significant disparity in the rate of osteoporosis screening between men and women. Among the elderly men and women in their patient population, 60% of women underwent screening compared with only 18.4% of men.¹⁰ This gender disparity potentially represents significant physician bias regarding the risk of osteoporosis and offers an important opportunity for orthopedic surgeons to improve preventative care for this population.

Preventative care in terms of advocating for bone health should not be limited to patients presenting with fragility fractures. Education regarding smoking cessation, resistance exercise, and calcium intake are relevant to many orthopedic patients. With the advent of the electronic medical record system, a simple intervention could easily ensure that patients report on their calcium intake. A trial published in 2006 found that a simple reminder from the electronic medical record improved osteoporosis management following a fragility fracture.¹¹ This type of intervention could certainly be expanded to include counseling on calcium and vitamin D for any orthopedic patient.

Another area in which orthopedic surgeons have an opportunity to practice good preventative care is injury prevention. Several studies examining fall prevention among the elderly have shown that physical therapy or exercise may decrease the rate of falls.¹² Promotion of activity and therapy among high-risk patients by orthopedic surgeons may help to reduce fracture incidence. Injury prevention is also relevant to young, healthy patients. It is well established that neuromuscular training helps to prevent anterior cruciate ligament injuries.¹³ Orthopedic surgeons have an opportunity during sports physicals or as team physicians to help promote injury prevention strategies. Discussion of training regimens may prevent overuse injuries among athletes. Moreover, faced with many patients who present with significant musculoskeletal trauma, orthopedic surgeons have the opportunity to offer education regarding motorcycle helmets, seatbelt use, and avoidance of drunk driving.

New orthopedic residency educational goals were recently published to include core competencies in resident education. Among these goals is to educate residents on care of a patient with hip fracture, including counseling and management of osteoporosis.¹⁴ These milestones could be expanded to include a thorough understanding of bone health. Residents should be able to make nutritional recommendations for any patient seen as an inpatient or outpatient, identify when a referral to an endocrinologist is needed, and educate patients regarding injury and fall prevention.

As healthcare expenditures rise, so does the impetus for physicians to work to improve efficiency in the healthcare system. Furthermore, the best possible care for our patients is to prevent injury and disability before it arises, rather than to depend on our ability to intervene after the fact. Residencies and training programs should work to incorporate preventative strategies into trainee education. Hospitals and outpatient settings should include a basic bone health questionnaire in the electronic medical record. The identification and management of risk factors for injury has the potential to help our patients and to help our healthcare system, but such intervention needs to start with the clinician.

By 2025, it is estimated that the annual cost of treating osteoporosis-related fractures in the United States will be 25 billion dollars, which is 10 billion dollars more than was spent in 2010.¹ As healthcare costs in the United States continue to skyrocket, it is imperative that orthopedic surgeons take an active role in avoiding preventable injury and disease. For orthopedic surgeons, preventative medicine will include promoting bone health and educating patients on injury prevention. By incorporating these principles into residency and fellowship education, and by leveraging the electronic medical record to support preventive care through systematic reminders, orthopedic surgeons have a critical opportunity to take a leading role in promoting prevention to our patients.

In 2009, the American Orthopaedic Association (AOA) launched a “Own the Bone” campaign, a national quality improvement program designed to optimize the treatment of osteoporosis.² This program came about following the Surgeon General’s call, in 2004, for orthopedic surgeons to take a more active role in treating osteoporosis. The program primarily aims to improve treatment of osteoporosis after a fragility fracture in an inpatient setting. Early results from a 2010 follow-up study showed that the new emphasis on prevention inspired by this program is effective. As compared with patients who had osteoporosis work-up and treatment initiated during their hospital admission, the group of patients who were referred for osteoporosis treatment after discharge were found to have a significantly lower rate of diagnosis and treatment.³ The loss of aftercare for patients who do not obtain immediate diagnosis and treatment for osteoporosis can and should be avoided. Many hospitals now have hip fracture services with multidisciplinary input. The successful outcomes of these programs include shorter times to the operating room, shorter hospital stays, decreased readmission, and decreased 30-day mortality.^4-6 These services provide an excellent opportunity to ensure that each patient has initiated management of osteoporosis before discharge. Ideally, patients would be scheduled for bone mineral density testing prior to leaving the hospital, when applicable, and would begin calcium and vitamin D supplementation or bisphosphonate treatment in the hospital, when appropriate. As part of these hip fracture services, a goal of clearly initiating or managing treatment for osteoporosis should be routinely addressed.

While patients presenting with hip fractures are an easily identifiable high-risk population, other patients present in an outpatient setting following fragility fractures, such as distal radius or vertebral compression fractures. These patients should be considered for osteoporosis work-up and counseled accordingly. A recent study compared the efficacy of the orthopedic surgeon initiating bone mineral density testing after a distal radius fracture, compared with referring the patient back to their primary care physician for testing. The study found a significantly higher rate of patients going on to bone mineral density testing when the surgeon initiated this process.⁷ In the era of improved digital communication, the outpatient setting offers an opportunity for clinicians to communicate with patients’ primary care physicians and initiate a multidisciplinary approach to bone health and prevention. In the outpatient setting, the orthopedist can address nutritional issues and screening on a repeated basis. Studies have demonstrated that physician counseling can be very effective in changing behavior and helping patients to stop using tobacco.⁸ In this vein, efforts by the physician to encourage calcium and vitamin D intake and weight-bearing exercise have the potential to be very effective.

Programs such as “Own the Bone” are crucial to orthopedists’ treatment of osteoporosis, but prevention of bone disease and fragility fracture must extend even further. Individual practitioners must be cognizant that many patients may benefit from outpatient diagnosis of osteoporosis and initiation of appropriate treatment, before fragility fractures occur. Moreover, although patients at high risk include post-menopausal women, orthopedists need to be consistently aware of osteoporosis as a disease of both genders. An estimated 2.8 million men in the United States have osteoporosis.⁹ A 2012 study published out of Washington, DC found a significant disparity in the rate of osteoporosis screening between men and women. Among the elderly men and women in their patient population, 60% of women underwent screening compared with only 18.4% of men.¹⁰ This gender disparity potentially represents significant physician bias regarding the risk of osteoporosis and offers an important opportunity for orthopedic surgeons to improve preventative care for this population.

Preventative care in terms of advocating for bone health should not be limited to patients presenting with fragility fractures. Education regarding smoking cessation, resistance exercise, and calcium intake are relevant to many orthopedic patients. With the advent of the electronic medical record system, a simple intervention could easily ensure that patients report on their calcium intake. A trial published in 2006 found that a simple reminder from the electronic medical record improved osteoporosis management following a fragility fracture.¹¹ This type of intervention could certainly be expanded to include counseling on calcium and vitamin D for any orthopedic patient.

Another area in which orthopedic surgeons have an opportunity to practice good preventative care is injury prevention. Several studies examining fall prevention among the elderly have shown that physical therapy or exercise may decrease the rate of falls.¹² Promotion of activity and therapy among high-risk patients by orthopedic surgeons may help to reduce fracture incidence. Injury prevention is also relevant to young, healthy patients. It is well established that neuromuscular training helps to prevent anterior cruciate ligament injuries.¹³ Orthopedic surgeons have an opportunity during sports physicals or as team physicians to help promote injury prevention strategies. Discussion of training regimens may prevent overuse injuries among athletes. Moreover, faced with many patients who present with significant musculoskeletal trauma, orthopedic surgeons have the opportunity to offer education regarding motorcycle helmets, seatbelt use, and avoidance of drunk driving.

New orthopedic residency educational goals were recently published to include core competencies in resident education. Among these goals is to educate residents on care of a patient with hip fracture, including counseling and management of osteoporosis.¹⁴ These milestones could be expanded to include a thorough understanding of bone health. Residents should be able to make nutritional recommendations for any patient seen as an inpatient or outpatient, identify when a referral to an endocrinologist is needed, and educate patients regarding injury and fall prevention.

As healthcare expenditures rise, so does the impetus for physicians to work to improve efficiency in the healthcare system. Furthermore, the best possible care for our patients is to prevent injury and disability before it arises, rather than to depend on our ability to intervene after the fact. Residencies and training programs should work to incorporate preventative strategies into trainee education. Hospitals and outpatient settings should include a basic bone health questionnaire in the electronic medical record. The identification and management of risk factors for injury has the potential to help our patients and to help our healthcare system, but such intervention needs to start with the clinician.

By 2025, it is estimated that the annual cost of treating osteoporosis-related fractures in the United States will be 25 billion dollars, which is 10 billion dollars more than was spent in 2010.¹ As healthcare costs in the United States continue to skyrocket, it is imperative that orthopedic surgeons take an active role in avoiding preventable injury and disease. For orthopedic surgeons, preventative medicine will include promoting bone health and educating patients on injury prevention. By incorporating these principles into residency and fellowship education, and by leveraging the electronic medical record to support preventive care through systematic reminders, orthopedic surgeons have a critical opportunity to take a leading role in promoting prevention to our patients.

In 2009, the American Orthopaedic Association (AOA) launched a “Own the Bone” campaign, a national quality improvement program designed to optimize the treatment of osteoporosis.² This program came about following the Surgeon General’s call, in 2004, for orthopedic surgeons to take a more active role in treating osteoporosis. The program primarily aims to improve treatment of osteoporosis after a fragility fracture in an inpatient setting. Early results from a 2010 follow-up study showed that the new emphasis on prevention inspired by this program is effective. As compared with patients who had osteoporosis work-up and treatment initiated during their hospital admission, the group of patients who were referred for osteoporosis treatment after discharge were found to have a significantly lower rate of diagnosis and treatment.³ The loss of aftercare for patients who do not obtain immediate diagnosis and treatment for osteoporosis can and should be avoided. Many hospitals now have hip fracture services with multidisciplinary input. The successful outcomes of these programs include shorter times to the operating room, shorter hospital stays, decreased readmission, and decreased 30-day mortality.^4-6 These services provide an excellent opportunity to ensure that each patient has initiated management of osteoporosis before discharge. Ideally, patients would be scheduled for bone mineral density testing prior to leaving the hospital, when applicable, and would begin calcium and vitamin D supplementation or bisphosphonate treatment in the hospital, when appropriate. As part of these hip fracture services, a goal of clearly initiating or managing treatment for osteoporosis should be routinely addressed.

While patients presenting with hip fractures are an easily identifiable high-risk population, other patients present in an outpatient setting following fragility fractures, such as distal radius or vertebral compression fractures. These patients should be considered for osteoporosis work-up and counseled accordingly. A recent study compared the efficacy of the orthopedic surgeon initiating bone mineral density testing after a distal radius fracture, compared with referring the patient back to their primary care physician for testing. The study found a significantly higher rate of patients going on to bone mineral density testing when the surgeon initiated this process.⁷ In the era of improved digital communication, the outpatient setting offers an opportunity for clinicians to communicate with patients’ primary care physicians and initiate a multidisciplinary approach to bone health and prevention. In the outpatient setting, the orthopedist can address nutritional issues and screening on a repeated basis. Studies have demonstrated that physician counseling can be very effective in changing behavior and helping patients to stop using tobacco.⁸ In this vein, efforts by the physician to encourage calcium and vitamin D intake and weight-bearing exercise have the potential to be very effective.

Programs such as “Own the Bone” are crucial to orthopedists’ treatment of osteoporosis, but prevention of bone disease and fragility fracture must extend even further. Individual practitioners must be cognizant that many patients may benefit from outpatient diagnosis of osteoporosis and initiation of appropriate treatment, before fragility fractures occur. Moreover, although patients at high risk include post-menopausal women, orthopedists need to be consistently aware of osteoporosis as a disease of both genders. An estimated 2.8 million men in the United States have osteoporosis.⁹ A 2012 study published out of Washington, DC found a significant disparity in the rate of osteoporosis screening between men and women. Among the elderly men and women in their patient population, 60% of women underwent screening compared with only 18.4% of men.¹⁰ This gender disparity potentially represents significant physician bias regarding the risk of osteoporosis and offers an important opportunity for orthopedic surgeons to improve preventative care for this population.

Preventative care in terms of advocating for bone health should not be limited to patients presenting with fragility fractures. Education regarding smoking cessation, resistance exercise, and calcium intake are relevant to many orthopedic patients. With the advent of the electronic medical record system, a simple intervention could easily ensure that patients report on their calcium intake. A trial published in 2006 found that a simple reminder from the electronic medical record improved osteoporosis management following a fragility fracture.¹¹ This type of intervention could certainly be expanded to include counseling on calcium and vitamin D for any orthopedic patient.

Another area in which orthopedic surgeons have an opportunity to practice good preventative care is injury prevention. Several studies examining fall prevention among the elderly have shown that physical therapy or exercise may decrease the rate of falls.¹² Promotion of activity and therapy among high-risk patients by orthopedic surgeons may help to reduce fracture incidence. Injury prevention is also relevant to young, healthy patients. It is well established that neuromuscular training helps to prevent anterior cruciate ligament injuries.¹³ Orthopedic surgeons have an opportunity during sports physicals or as team physicians to help promote injury prevention strategies. Discussion of training regimens may prevent overuse injuries among athletes. Moreover, faced with many patients who present with significant musculoskeletal trauma, orthopedic surgeons have the opportunity to offer education regarding motorcycle helmets, seatbelt use, and avoidance of drunk driving.

New orthopedic residency educational goals were recently published to include core competencies in resident education. Among these goals is to educate residents on care of a patient with hip fracture, including counseling and management of osteoporosis.¹⁴ These milestones could be expanded to include a thorough understanding of bone health. Residents should be able to make nutritional recommendations for any patient seen as an inpatient or outpatient, identify when a referral to an endocrinologist is needed, and educate patients regarding injury and fall prevention.

As healthcare expenditures rise, so does the impetus for physicians to work to improve efficiency in the healthcare system. Furthermore, the best possible care for our patients is to prevent injury and disability before it arises, rather than to depend on our ability to intervene after the fact. Residencies and training programs should work to incorporate preventative strategies into trainee education. Hospitals and outpatient settings should include a basic bone health questionnaire in the electronic medical record. The identification and management of risk factors for injury has the potential to help our patients and to help our healthcare system, but such intervention needs to start with the clinician.

ABSTRACT

A patient’s perception of hospital or provider quality can have far-reaching effects, as it can impact reimbursement, patient selection of a surgeon, and healthcare competition. A variety of organizations offer quality designations for orthopedic surgery and its subspecialties. Our goal is to compare total joint arthroplasty (TJA) quality designation methodology across key quality rating organizations. One researcher conducted an initial Google search to determine organizations providing quality designations for hospitals and surgeons providing orthopedic procedures with a focus on TJA. Organizations that offer quality designation specific to TJA were determined. Organizations that provided general orthopedic surgery or only surgeon-specific quality designation were excluded from the analysis. The senior author confirmed the inclusion of the final organizations. Seven organizations fit our inclusion criteria. Only the private payers and The Joint Commission required hospital accreditation to meet quality designation criteria. Total arthroplasty volume was considered in 86% of the organizations’ methodologies, and 57% of organizations utilized process measurements such as antibiotic prophylaxis and care pathways. In addition, 57% of organizations included patient experience in their methodologies. Only 29% of organizations included a cost element in their methodology. All organizations utilized outcome data and publicly reported all hospitals receiving their quality designation. Hospital quality designation methodologies are inconsistent in the context of TJA. All stakeholders (ie, providers, payers, and patients) should be involved in deciding the definition of quality.

Continue to: Healthcare in the United States...

Healthcare in the United States has begun to move toward a system focused on value for patients, defined as health outcome per dollar expended.¹ Indeed, an estimated 30% of Medicare payments are now made using the so-called alternative payment models (eg, bundled payments),² and there is an expectation that consumerism in medicine will continue to expand.³ In addition, although there is a continuing debate regarding the benefits and pitfalls of hospital mergers, there is no question whether provider consolidation has increased dramatically in recent years.⁴ At the core of many of these changes is the push to improve healthcare quality and reduce costs.

Quality has the ability to affect payment, patient selection of providers, and hospital competition. Patients (ie, healthcare consumers) are increasingly using the Internet to find a variety of health information.⁵ Accessible provider quality information online would allow patients to make more informed decisions about where to seek care. In addition, the development of transparent quality ratings could assist payers in driving beneficiaries to higher quality and better value providers, which could mean more business for the highest quality physicians and better patient outcomes with fewer complications. Some payers such as the Centers for Medicare and Medicaid Services (CMS) have already started using quality measures as part of their reimbursement strategy.⁶ Because CMS is the largest payer in the United States, private insurers tend to follow their lead; thus, quality measurements will become even more common as a factor in reimbursement over the coming years.

To make quality ratings useful, “quality” must be clearly defined. Clarity around which factors are considered in a quality designation will create transparency for patients and allow providers to understand how their performance is being measured so that they focus on improving outcomes for their patients. Numerous organizations, including private payers, public payers, and both not-for-profit and for-profit entities, have created quality designation programs to rate providers. However, within orthopedics and several other medical specialties, there has been an ongoing debate about what measures best reflect quality.⁷ Although inconsistencies in quality ratings in arthroplasty care have been noted,⁸ it remains unknown how each quality designation program compares with the others in terms of the factors considered in deciding quality designations.

The purpose of this study is to evaluate publicly available information from key quality designation programs for total joint arthroplasty (TJA) providers to determine what factors are considered by each organization in awarding quality designations; what similarities and differences in quality designations exist across the different organizations; and how many of the organizations publish their quality designation methodologies and final rating results.

MATERIALS AND METHODS

A directed Google search was conducted to determine organizations (ie, payers, independent firms, and government entities) that rate hospitals and/or surgeons in orthopedic surgery. The identified organizations were then examined to determine whether they provided hospital ratings for total hip and/or knee arthroplasty. Entities were included if they provided quality designations for hospitals specifically addressing TJA. Organizations that provided only general hospital, other surgical procedures, orthopedic surgery, or orthopedic surgeon-specific quality designations were excluded. A list of all organizations determined to fit the inclusion criteria was then reviewed for completeness and approved by the senior author.

Continue to: One investigator reviewed the website of each organization...

One investigator reviewed the website of each organization fitting the inclusion criteria to determine the full rating methodology in 1 sitting on July 2, 2016. Detailed notes were taken on each program using publicly available information. For organizations that used proprietary criteria for quality designation (eg, The Joint Commission [TJC]), only publicly available information was used in the analysis. Therefore, the information reported is solely based on data available online to the public.

Detailed quality designation criteria were condensed into broader categories (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency) to capture differences between each organization reviewed. In addition, we recorded whether each organization published a list of providers that received its quality designation.  

RESULTS

A total of 7 organizations fit our inclusion criteria^9-15 (Table). Of these 7 organizations, 3 were private payers (Aetna, UnitedHealth, and Blue Cross Blue Shield [BCBS]), 2 were nongovernmental not-for-profit organizations (TJC and Consumer Reports), and 2 were consumer-based and/or for-profit organizations (HealthGrades and US News & World Report [USNWR]). There were no government agencies that fit our inclusion criteria. BCBS had the following 2 separate quality designations: BCBS Blue Distinction and BCBS Blue Distinction+. The only difference between the 2 BCBS ratings is that BCBS Blue Distinction+ includes cost efficiency ratings, whereas BCBS Blue Distinction does not.

Only the 3 private payers and TJC, the primary hospital accreditation body in the United States, required accreditation as part of its quality designation criteria. TJC requires its own accreditation for quality designation consideration, whereas the 3 private payers allow accreditation from one of a variety of sources. Aetna Institutes of Quality for Orthopedic Surgery requires accreditation by TJC, Healthcare Facilities Accreditation Program, American Osteopathic Association, National Integrated Accreditation for Healthcare Organizations, or Det Norske Veritas Healthcare. UnitedHealth Premium Total Joint Replacement (TJR) Specialty Center requires accreditation by TJC and/or equivalent of TJC accreditation. However, TJC accreditation equivalents are not noted in the UnitedHealth handbook. BCBS Blue Distinction and Distinction+ require accreditation by TJC, Healthcare Facilities Accreditation Program, National Integrated Accreditation for Healthcare Organizations, or Center for Improvement in Healthcare Quality. In addition, BCBS is willing to consider alternative accreditations that are at least as stringent as the national alternatives noted. However, no detailed criteria that must be met to be equivalent to the national standards are noted in the relevant quality designation handbook.

The volume of completed total hip and knee arthroplasty procedures was considered in 6 of the organizations’ quality ratings methodologies. Of those 6, all private payers, TJC (not-for-profit), and 2 for-profit rating agencies were included. Surgeon specialization in TJA was only explicitly noted as a factor considered in UnitedHealth Premium TJR Specialty Center criteria; however, the requirements for surgeon specialization were not clearly defined. In addition, the presence of a multidisciplinary clinical pathway was only explicitly considered for Aetna Institutes of Quality for Orthopedic Surgery.

Structural requirements (eg, use of electronic health records [EHR], staffing levels, etc.) were taken into account in private payer and USNWR quality methodologies. Process measures (eg, antibiotic prophylaxis and other care pathways) were considered for the private payers and TJC but not for USNWR quality designation. Cost and/or efficiency measures were factors in the quality formula for Aetna Institutes of Quality for Orthopedic Surgery and BCBS Distinction+. Aetna utilizes its own cost data and risk-adjusts using a product known as Symmetry Episode Risk Groups to determine cost-effectiveness, while BCBS uses its own Composite Facility Cost Index. Patient experience (eg, Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS]) was incorporated into the quality formulas for 4 of the 7 quality designation programs examined.

Continue to: All of the 7 quality designation programs included...

All of the 7 quality designation programs included outcomes (ie, readmission rates and/or mortality rates) and publicly reported the hospitals receiving their quality designation. In contrast, only Aetna explicitly included the presence of multidisciplinary clinical care pathways as part of their quality designation criteria. In addition, only UnitedHealth included surgeon specialization in joint arthroplasty as a factor for quality consideration for its quality designation program. BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery were the only 2 quality designations that included at least 1 variable that fit into each of the 7 characteristics considered (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency).

DISCUSSION

As healthcare continues to shift toward value-based delivery and payment models, quality becomes a critical factor in reimbursement and provider rankings. However, quality is a vague term. Several providers probably do not know what is required to be designated as high quality by a particular rating agency. Moreover, there are multiple quality designation programs, all using distinct criteria to determine “quality,” which further complicates the matter. Our objective was to determine the key stakeholders that provide quality designations in TJA and what criteria each organization uses in assessing quality.

Our idea of comprehensive quality is based on Avedis Donabedian’s enduring framework for healthcare quality focused on structure, process, and outcome.¹⁶ We expanded on these 3 areas and analyzed quality designations based on variables fitting into the following categories: accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency. We believe that these categories encompass a comprehensive rating system that addresses key elements of patient care. However, our results suggest that only 2 major quality designations (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery) take all such variables into account.

All quality designation programs that we analyzed required outcome data (ie, readmission and/or mortality rates within 30 days); however, only 2 programs utilized cost in their quality designation criteria (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Aetna Institutes of Quality for Orthopedic Surgery risk-adjusted for its cost-effectiveness calculations based on age, sex, and other unspecified conditions using a product known as Symmetry Episode Risk Groups. However, the organization also noted that although it did risk-adjust for inpatient mortality, it did not do so for pulmonary embolism or deep vein thrombosis. BCBS Distinction+ also utilized risk adjustment for its cost efficiency measure, and its step-by-step methodology is available online. Further, Consumer Reports does risk-adjust using logistic regression models in their quality analysis, but the description provided is minimal; it is noted that such risk adjustments are already completed by CMS prior to Consumer Reports acquiring the data. The CMS Compare model information is available on the CMS website. The data utilized by several organizations and presented on CMS Compare are already risk-adjusted using CMS’ approach. In contrast, UnitedHealth Premium TJR Specialty Center gathers its own data from providers and does not describe a risk adjustment methodology. Risk adjustment is important because the lack of risk adjustment may lead to physicians “cherry-picking” easy cases to boost positive outcomes, leading to increased financial benefits and higher quality ratings. Having a consistent risk adjustment formula will ensure accurate comparisons across outcomes and cost-effectiveness measures used by quality designation programs.

Factors considered for quality designation varied greatly from one organization to the other. The range of categories of factors considered varied from 1 (Consumer Reports only considered outcome data) to all 7 categories (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Our findings are consistent with the work by Keswani and colleagues,⁸ which showed that there is likely variation in factors considered when rating hospital quality more broadly. Our work suggests that quality designation formulas do not appear to get more consistent when focused on TJA.

We found that all organizations in our analysis published the providers earning their quality designation. However, TJC does not provide publicly a detailed methodology on how to qualify for its quality designation. The price to purchase the necessary manual for this information is $146.00 for accredited organizations and $186.00 for all others.¹⁷ For large healthcare providers, this is not a large sum of money. Nonetheless, this provides an additional hurdle for stakeholders to gain a full understanding of the requirements to receive a TJC Gold Seal for Orthopedics.

Previous work has evaluated the consistency of and the variety of means of gauging healthcare quality. Previous work by Rothberg and colleagues¹⁸ comparing hospital rankings across 5 common consumer-oriented websites found disagreement on hospital rankings within any diagnosis and even among metrics such as mortality. Another study by Halasyamani and Davis¹⁹ found that CMS Compare and USNWR rankings were dissimilar and the authors attributed the discrepancy to different methodologies. In addition, a study by Krumholz and colleagues²⁰ focused on Internet report cards, which measured the appropriate use of select medications and mortality rates for acute myocardial infarction as the quality metrics. The authors found that, in aggregate, there was a clear difference in quality of care and outcomes but that comparisons between 2 hospitals provided poor discrimination.²⁰ Other work has analyzed the increasing trend of online ratings of orthopedic surgeons by patients.²¹ However, there remains no agreed-upon definition of quality. Thus, the use of the term “quality” in several studies may be misleading.

Our results must be interpreted keeping the limitations of our work in mind. First, we used expert knowledge and a public search engine to develop our list of organizations that provide TJA quality designations. However, there is a possibility that we did not include all relevant organizations. Second, although all authors reviewed the final data, it is possible that there was human error in the analysis of each organization’s quality designation criteria.

CONCLUSION

As healthcare progresses further toward a system that rewards providers for delivering value to patients, accurately defining and measuring quality becomes critical because it can be suggestive of value to patients, payers, and providers. Furthermore, it gives providers a goal to focus on as they strive to improve the value of care they deliver to patients. Measuring healthcare quality is currently a novel, imperfect science,²² and there continues to be a debate about what factors should be included in a quality designation formula. Nonetheless, more and more quality designations and performance measurements are being created for orthopedic care, including total hip and total knee arthroplasty. In fact, in 2016, The Leapfrog Group added readmission for patients undergoing TJA to its survey.²³ Consensus on a quality definition may facilitate the movement toward a value-based healthcare system. Future research should evaluate strategies for gaining consensus among stakeholders for a universal quality metric in TJA. Surgeons, hospitals, payers, and most importantly patients should play critical roles in defining quality.

ABSTRACT

A patient’s perception of hospital or provider quality can have far-reaching effects, as it can impact reimbursement, patient selection of a surgeon, and healthcare competition. A variety of organizations offer quality designations for orthopedic surgery and its subspecialties. Our goal is to compare total joint arthroplasty (TJA) quality designation methodology across key quality rating organizations. One researcher conducted an initial Google search to determine organizations providing quality designations for hospitals and surgeons providing orthopedic procedures with a focus on TJA. Organizations that offer quality designation specific to TJA were determined. Organizations that provided general orthopedic surgery or only surgeon-specific quality designation were excluded from the analysis. The senior author confirmed the inclusion of the final organizations. Seven organizations fit our inclusion criteria. Only the private payers and The Joint Commission required hospital accreditation to meet quality designation criteria. Total arthroplasty volume was considered in 86% of the organizations’ methodologies, and 57% of organizations utilized process measurements such as antibiotic prophylaxis and care pathways. In addition, 57% of organizations included patient experience in their methodologies. Only 29% of organizations included a cost element in their methodology. All organizations utilized outcome data and publicly reported all hospitals receiving their quality designation. Hospital quality designation methodologies are inconsistent in the context of TJA. All stakeholders (ie, providers, payers, and patients) should be involved in deciding the definition of quality.

Continue to: Healthcare in the United States...

Healthcare in the United States has begun to move toward a system focused on value for patients, defined as health outcome per dollar expended.¹ Indeed, an estimated 30% of Medicare payments are now made using the so-called alternative payment models (eg, bundled payments),² and there is an expectation that consumerism in medicine will continue to expand.³ In addition, although there is a continuing debate regarding the benefits and pitfalls of hospital mergers, there is no question whether provider consolidation has increased dramatically in recent years.⁴ At the core of many of these changes is the push to improve healthcare quality and reduce costs.

Quality has the ability to affect payment, patient selection of providers, and hospital competition. Patients (ie, healthcare consumers) are increasingly using the Internet to find a variety of health information.⁵ Accessible provider quality information online would allow patients to make more informed decisions about where to seek care. In addition, the development of transparent quality ratings could assist payers in driving beneficiaries to higher quality and better value providers, which could mean more business for the highest quality physicians and better patient outcomes with fewer complications. Some payers such as the Centers for Medicare and Medicaid Services (CMS) have already started using quality measures as part of their reimbursement strategy.⁶ Because CMS is the largest payer in the United States, private insurers tend to follow their lead; thus, quality measurements will become even more common as a factor in reimbursement over the coming years.

To make quality ratings useful, “quality” must be clearly defined. Clarity around which factors are considered in a quality designation will create transparency for patients and allow providers to understand how their performance is being measured so that they focus on improving outcomes for their patients. Numerous organizations, including private payers, public payers, and both not-for-profit and for-profit entities, have created quality designation programs to rate providers. However, within orthopedics and several other medical specialties, there has been an ongoing debate about what measures best reflect quality.⁷ Although inconsistencies in quality ratings in arthroplasty care have been noted,⁸ it remains unknown how each quality designation program compares with the others in terms of the factors considered in deciding quality designations.

The purpose of this study is to evaluate publicly available information from key quality designation programs for total joint arthroplasty (TJA) providers to determine what factors are considered by each organization in awarding quality designations; what similarities and differences in quality designations exist across the different organizations; and how many of the organizations publish their quality designation methodologies and final rating results.

MATERIALS AND METHODS

A directed Google search was conducted to determine organizations (ie, payers, independent firms, and government entities) that rate hospitals and/or surgeons in orthopedic surgery. The identified organizations were then examined to determine whether they provided hospital ratings for total hip and/or knee arthroplasty. Entities were included if they provided quality designations for hospitals specifically addressing TJA. Organizations that provided only general hospital, other surgical procedures, orthopedic surgery, or orthopedic surgeon-specific quality designations were excluded. A list of all organizations determined to fit the inclusion criteria was then reviewed for completeness and approved by the senior author.

Continue to: One investigator reviewed the website of each organization...

One investigator reviewed the website of each organization fitting the inclusion criteria to determine the full rating methodology in 1 sitting on July 2, 2016. Detailed notes were taken on each program using publicly available information. For organizations that used proprietary criteria for quality designation (eg, The Joint Commission [TJC]), only publicly available information was used in the analysis. Therefore, the information reported is solely based on data available online to the public.

Detailed quality designation criteria were condensed into broader categories (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency) to capture differences between each organization reviewed. In addition, we recorded whether each organization published a list of providers that received its quality designation.  

RESULTS

A total of 7 organizations fit our inclusion criteria^9-15 (Table). Of these 7 organizations, 3 were private payers (Aetna, UnitedHealth, and Blue Cross Blue Shield [BCBS]), 2 were nongovernmental not-for-profit organizations (TJC and Consumer Reports), and 2 were consumer-based and/or for-profit organizations (HealthGrades and US News & World Report [USNWR]). There were no government agencies that fit our inclusion criteria. BCBS had the following 2 separate quality designations: BCBS Blue Distinction and BCBS Blue Distinction+. The only difference between the 2 BCBS ratings is that BCBS Blue Distinction+ includes cost efficiency ratings, whereas BCBS Blue Distinction does not.

Only the 3 private payers and TJC, the primary hospital accreditation body in the United States, required accreditation as part of its quality designation criteria. TJC requires its own accreditation for quality designation consideration, whereas the 3 private payers allow accreditation from one of a variety of sources. Aetna Institutes of Quality for Orthopedic Surgery requires accreditation by TJC, Healthcare Facilities Accreditation Program, American Osteopathic Association, National Integrated Accreditation for Healthcare Organizations, or Det Norske Veritas Healthcare. UnitedHealth Premium Total Joint Replacement (TJR) Specialty Center requires accreditation by TJC and/or equivalent of TJC accreditation. However, TJC accreditation equivalents are not noted in the UnitedHealth handbook. BCBS Blue Distinction and Distinction+ require accreditation by TJC, Healthcare Facilities Accreditation Program, National Integrated Accreditation for Healthcare Organizations, or Center for Improvement in Healthcare Quality. In addition, BCBS is willing to consider alternative accreditations that are at least as stringent as the national alternatives noted. However, no detailed criteria that must be met to be equivalent to the national standards are noted in the relevant quality designation handbook.

The volume of completed total hip and knee arthroplasty procedures was considered in 6 of the organizations’ quality ratings methodologies. Of those 6, all private payers, TJC (not-for-profit), and 2 for-profit rating agencies were included. Surgeon specialization in TJA was only explicitly noted as a factor considered in UnitedHealth Premium TJR Specialty Center criteria; however, the requirements for surgeon specialization were not clearly defined. In addition, the presence of a multidisciplinary clinical pathway was only explicitly considered for Aetna Institutes of Quality for Orthopedic Surgery.

Structural requirements (eg, use of electronic health records [EHR], staffing levels, etc.) were taken into account in private payer and USNWR quality methodologies. Process measures (eg, antibiotic prophylaxis and other care pathways) were considered for the private payers and TJC but not for USNWR quality designation. Cost and/or efficiency measures were factors in the quality formula for Aetna Institutes of Quality for Orthopedic Surgery and BCBS Distinction+. Aetna utilizes its own cost data and risk-adjusts using a product known as Symmetry Episode Risk Groups to determine cost-effectiveness, while BCBS uses its own Composite Facility Cost Index. Patient experience (eg, Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS]) was incorporated into the quality formulas for 4 of the 7 quality designation programs examined.

Continue to: All of the 7 quality designation programs included...

All of the 7 quality designation programs included outcomes (ie, readmission rates and/or mortality rates) and publicly reported the hospitals receiving their quality designation. In contrast, only Aetna explicitly included the presence of multidisciplinary clinical care pathways as part of their quality designation criteria. In addition, only UnitedHealth included surgeon specialization in joint arthroplasty as a factor for quality consideration for its quality designation program. BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery were the only 2 quality designations that included at least 1 variable that fit into each of the 7 characteristics considered (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency).

DISCUSSION

As healthcare continues to shift toward value-based delivery and payment models, quality becomes a critical factor in reimbursement and provider rankings. However, quality is a vague term. Several providers probably do not know what is required to be designated as high quality by a particular rating agency. Moreover, there are multiple quality designation programs, all using distinct criteria to determine “quality,” which further complicates the matter. Our objective was to determine the key stakeholders that provide quality designations in TJA and what criteria each organization uses in assessing quality.

Our idea of comprehensive quality is based on Avedis Donabedian’s enduring framework for healthcare quality focused on structure, process, and outcome.¹⁶ We expanded on these 3 areas and analyzed quality designations based on variables fitting into the following categories: accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency. We believe that these categories encompass a comprehensive rating system that addresses key elements of patient care. However, our results suggest that only 2 major quality designations (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery) take all such variables into account.

All quality designation programs that we analyzed required outcome data (ie, readmission and/or mortality rates within 30 days); however, only 2 programs utilized cost in their quality designation criteria (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Aetna Institutes of Quality for Orthopedic Surgery risk-adjusted for its cost-effectiveness calculations based on age, sex, and other unspecified conditions using a product known as Symmetry Episode Risk Groups. However, the organization also noted that although it did risk-adjust for inpatient mortality, it did not do so for pulmonary embolism or deep vein thrombosis. BCBS Distinction+ also utilized risk adjustment for its cost efficiency measure, and its step-by-step methodology is available online. Further, Consumer Reports does risk-adjust using logistic regression models in their quality analysis, but the description provided is minimal; it is noted that such risk adjustments are already completed by CMS prior to Consumer Reports acquiring the data. The CMS Compare model information is available on the CMS website. The data utilized by several organizations and presented on CMS Compare are already risk-adjusted using CMS’ approach. In contrast, UnitedHealth Premium TJR Specialty Center gathers its own data from providers and does not describe a risk adjustment methodology. Risk adjustment is important because the lack of risk adjustment may lead to physicians “cherry-picking” easy cases to boost positive outcomes, leading to increased financial benefits and higher quality ratings. Having a consistent risk adjustment formula will ensure accurate comparisons across outcomes and cost-effectiveness measures used by quality designation programs.

Factors considered for quality designation varied greatly from one organization to the other. The range of categories of factors considered varied from 1 (Consumer Reports only considered outcome data) to all 7 categories (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Our findings are consistent with the work by Keswani and colleagues,⁸ which showed that there is likely variation in factors considered when rating hospital quality more broadly. Our work suggests that quality designation formulas do not appear to get more consistent when focused on TJA.

We found that all organizations in our analysis published the providers earning their quality designation. However, TJC does not provide publicly a detailed methodology on how to qualify for its quality designation. The price to purchase the necessary manual for this information is $146.00 for accredited organizations and $186.00 for all others.¹⁷ For large healthcare providers, this is not a large sum of money. Nonetheless, this provides an additional hurdle for stakeholders to gain a full understanding of the requirements to receive a TJC Gold Seal for Orthopedics.

Previous work has evaluated the consistency of and the variety of means of gauging healthcare quality. Previous work by Rothberg and colleagues¹⁸ comparing hospital rankings across 5 common consumer-oriented websites found disagreement on hospital rankings within any diagnosis and even among metrics such as mortality. Another study by Halasyamani and Davis¹⁹ found that CMS Compare and USNWR rankings were dissimilar and the authors attributed the discrepancy to different methodologies. In addition, a study by Krumholz and colleagues²⁰ focused on Internet report cards, which measured the appropriate use of select medications and mortality rates for acute myocardial infarction as the quality metrics. The authors found that, in aggregate, there was a clear difference in quality of care and outcomes but that comparisons between 2 hospitals provided poor discrimination.²⁰ Other work has analyzed the increasing trend of online ratings of orthopedic surgeons by patients.²¹ However, there remains no agreed-upon definition of quality. Thus, the use of the term “quality” in several studies may be misleading.

Our results must be interpreted keeping the limitations of our work in mind. First, we used expert knowledge and a public search engine to develop our list of organizations that provide TJA quality designations. However, there is a possibility that we did not include all relevant organizations. Second, although all authors reviewed the final data, it is possible that there was human error in the analysis of each organization’s quality designation criteria.

CONCLUSION

As healthcare progresses further toward a system that rewards providers for delivering value to patients, accurately defining and measuring quality becomes critical because it can be suggestive of value to patients, payers, and providers. Furthermore, it gives providers a goal to focus on as they strive to improve the value of care they deliver to patients. Measuring healthcare quality is currently a novel, imperfect science,²² and there continues to be a debate about what factors should be included in a quality designation formula. Nonetheless, more and more quality designations and performance measurements are being created for orthopedic care, including total hip and total knee arthroplasty. In fact, in 2016, The Leapfrog Group added readmission for patients undergoing TJA to its survey.²³ Consensus on a quality definition may facilitate the movement toward a value-based healthcare system. Future research should evaluate strategies for gaining consensus among stakeholders for a universal quality metric in TJA. Surgeons, hospitals, payers, and most importantly patients should play critical roles in defining quality.

ABSTRACT

A patient’s perception of hospital or provider quality can have far-reaching effects, as it can impact reimbursement, patient selection of a surgeon, and healthcare competition. A variety of organizations offer quality designations for orthopedic surgery and its subspecialties. Our goal is to compare total joint arthroplasty (TJA) quality designation methodology across key quality rating organizations. One researcher conducted an initial Google search to determine organizations providing quality designations for hospitals and surgeons providing orthopedic procedures with a focus on TJA. Organizations that offer quality designation specific to TJA were determined. Organizations that provided general orthopedic surgery or only surgeon-specific quality designation were excluded from the analysis. The senior author confirmed the inclusion of the final organizations. Seven organizations fit our inclusion criteria. Only the private payers and The Joint Commission required hospital accreditation to meet quality designation criteria. Total arthroplasty volume was considered in 86% of the organizations’ methodologies, and 57% of organizations utilized process measurements such as antibiotic prophylaxis and care pathways. In addition, 57% of organizations included patient experience in their methodologies. Only 29% of organizations included a cost element in their methodology. All organizations utilized outcome data and publicly reported all hospitals receiving their quality designation. Hospital quality designation methodologies are inconsistent in the context of TJA. All stakeholders (ie, providers, payers, and patients) should be involved in deciding the definition of quality.

Continue to: Healthcare in the United States...

Healthcare in the United States has begun to move toward a system focused on value for patients, defined as health outcome per dollar expended.¹ Indeed, an estimated 30% of Medicare payments are now made using the so-called alternative payment models (eg, bundled payments),² and there is an expectation that consumerism in medicine will continue to expand.³ In addition, although there is a continuing debate regarding the benefits and pitfalls of hospital mergers, there is no question whether provider consolidation has increased dramatically in recent years.⁴ At the core of many of these changes is the push to improve healthcare quality and reduce costs.

Quality has the ability to affect payment, patient selection of providers, and hospital competition. Patients (ie, healthcare consumers) are increasingly using the Internet to find a variety of health information.⁵ Accessible provider quality information online would allow patients to make more informed decisions about where to seek care. In addition, the development of transparent quality ratings could assist payers in driving beneficiaries to higher quality and better value providers, which could mean more business for the highest quality physicians and better patient outcomes with fewer complications. Some payers such as the Centers for Medicare and Medicaid Services (CMS) have already started using quality measures as part of their reimbursement strategy.⁶ Because CMS is the largest payer in the United States, private insurers tend to follow their lead; thus, quality measurements will become even more common as a factor in reimbursement over the coming years.

To make quality ratings useful, “quality” must be clearly defined. Clarity around which factors are considered in a quality designation will create transparency for patients and allow providers to understand how their performance is being measured so that they focus on improving outcomes for their patients. Numerous organizations, including private payers, public payers, and both not-for-profit and for-profit entities, have created quality designation programs to rate providers. However, within orthopedics and several other medical specialties, there has been an ongoing debate about what measures best reflect quality.⁷ Although inconsistencies in quality ratings in arthroplasty care have been noted,⁸ it remains unknown how each quality designation program compares with the others in terms of the factors considered in deciding quality designations.

The purpose of this study is to evaluate publicly available information from key quality designation programs for total joint arthroplasty (TJA) providers to determine what factors are considered by each organization in awarding quality designations; what similarities and differences in quality designations exist across the different organizations; and how many of the organizations publish their quality designation methodologies and final rating results.

MATERIALS AND METHODS

A directed Google search was conducted to determine organizations (ie, payers, independent firms, and government entities) that rate hospitals and/or surgeons in orthopedic surgery. The identified organizations were then examined to determine whether they provided hospital ratings for total hip and/or knee arthroplasty. Entities were included if they provided quality designations for hospitals specifically addressing TJA. Organizations that provided only general hospital, other surgical procedures, orthopedic surgery, or orthopedic surgeon-specific quality designations were excluded. A list of all organizations determined to fit the inclusion criteria was then reviewed for completeness and approved by the senior author.

Continue to: One investigator reviewed the website of each organization...

One investigator reviewed the website of each organization fitting the inclusion criteria to determine the full rating methodology in 1 sitting on July 2, 2016. Detailed notes were taken on each program using publicly available information. For organizations that used proprietary criteria for quality designation (eg, The Joint Commission [TJC]), only publicly available information was used in the analysis. Therefore, the information reported is solely based on data available online to the public.

Detailed quality designation criteria were condensed into broader categories (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency) to capture differences between each organization reviewed. In addition, we recorded whether each organization published a list of providers that received its quality designation.  

RESULTS

A total of 7 organizations fit our inclusion criteria^9-15 (Table). Of these 7 organizations, 3 were private payers (Aetna, UnitedHealth, and Blue Cross Blue Shield [BCBS]), 2 were nongovernmental not-for-profit organizations (TJC and Consumer Reports), and 2 were consumer-based and/or for-profit organizations (HealthGrades and US News & World Report [USNWR]). There were no government agencies that fit our inclusion criteria. BCBS had the following 2 separate quality designations: BCBS Blue Distinction and BCBS Blue Distinction+. The only difference between the 2 BCBS ratings is that BCBS Blue Distinction+ includes cost efficiency ratings, whereas BCBS Blue Distinction does not.

Only the 3 private payers and TJC, the primary hospital accreditation body in the United States, required accreditation as part of its quality designation criteria. TJC requires its own accreditation for quality designation consideration, whereas the 3 private payers allow accreditation from one of a variety of sources. Aetna Institutes of Quality for Orthopedic Surgery requires accreditation by TJC, Healthcare Facilities Accreditation Program, American Osteopathic Association, National Integrated Accreditation for Healthcare Organizations, or Det Norske Veritas Healthcare. UnitedHealth Premium Total Joint Replacement (TJR) Specialty Center requires accreditation by TJC and/or equivalent of TJC accreditation. However, TJC accreditation equivalents are not noted in the UnitedHealth handbook. BCBS Blue Distinction and Distinction+ require accreditation by TJC, Healthcare Facilities Accreditation Program, National Integrated Accreditation for Healthcare Organizations, or Center for Improvement in Healthcare Quality. In addition, BCBS is willing to consider alternative accreditations that are at least as stringent as the national alternatives noted. However, no detailed criteria that must be met to be equivalent to the national standards are noted in the relevant quality designation handbook.

The volume of completed total hip and knee arthroplasty procedures was considered in 6 of the organizations’ quality ratings methodologies. Of those 6, all private payers, TJC (not-for-profit), and 2 for-profit rating agencies were included. Surgeon specialization in TJA was only explicitly noted as a factor considered in UnitedHealth Premium TJR Specialty Center criteria; however, the requirements for surgeon specialization were not clearly defined. In addition, the presence of a multidisciplinary clinical pathway was only explicitly considered for Aetna Institutes of Quality for Orthopedic Surgery.

Structural requirements (eg, use of electronic health records [EHR], staffing levels, etc.) were taken into account in private payer and USNWR quality methodologies. Process measures (eg, antibiotic prophylaxis and other care pathways) were considered for the private payers and TJC but not for USNWR quality designation. Cost and/or efficiency measures were factors in the quality formula for Aetna Institutes of Quality for Orthopedic Surgery and BCBS Distinction+. Aetna utilizes its own cost data and risk-adjusts using a product known as Symmetry Episode Risk Groups to determine cost-effectiveness, while BCBS uses its own Composite Facility Cost Index. Patient experience (eg, Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS]) was incorporated into the quality formulas for 4 of the 7 quality designation programs examined.

Continue to: All of the 7 quality designation programs included...

All of the 7 quality designation programs included outcomes (ie, readmission rates and/or mortality rates) and publicly reported the hospitals receiving their quality designation. In contrast, only Aetna explicitly included the presence of multidisciplinary clinical care pathways as part of their quality designation criteria. In addition, only UnitedHealth included surgeon specialization in joint arthroplasty as a factor for quality consideration for its quality designation program. BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery were the only 2 quality designations that included at least 1 variable that fit into each of the 7 characteristics considered (accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency).

DISCUSSION

As healthcare continues to shift toward value-based delivery and payment models, quality becomes a critical factor in reimbursement and provider rankings. However, quality is a vague term. Several providers probably do not know what is required to be designated as high quality by a particular rating agency. Moreover, there are multiple quality designation programs, all using distinct criteria to determine “quality,” which further complicates the matter. Our objective was to determine the key stakeholders that provide quality designations in TJA and what criteria each organization uses in assessing quality.

Our idea of comprehensive quality is based on Avedis Donabedian’s enduring framework for healthcare quality focused on structure, process, and outcome.¹⁶ We expanded on these 3 areas and analyzed quality designations based on variables fitting into the following categories: accreditation, volume, structural, process, outcomes, patient experience, and cost/efficiency. We believe that these categories encompass a comprehensive rating system that addresses key elements of patient care. However, our results suggest that only 2 major quality designations (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery) take all such variables into account.

All quality designation programs that we analyzed required outcome data (ie, readmission and/or mortality rates within 30 days); however, only 2 programs utilized cost in their quality designation criteria (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Aetna Institutes of Quality for Orthopedic Surgery risk-adjusted for its cost-effectiveness calculations based on age, sex, and other unspecified conditions using a product known as Symmetry Episode Risk Groups. However, the organization also noted that although it did risk-adjust for inpatient mortality, it did not do so for pulmonary embolism or deep vein thrombosis. BCBS Distinction+ also utilized risk adjustment for its cost efficiency measure, and its step-by-step methodology is available online. Further, Consumer Reports does risk-adjust using logistic regression models in their quality analysis, but the description provided is minimal; it is noted that such risk adjustments are already completed by CMS prior to Consumer Reports acquiring the data. The CMS Compare model information is available on the CMS website. The data utilized by several organizations and presented on CMS Compare are already risk-adjusted using CMS’ approach. In contrast, UnitedHealth Premium TJR Specialty Center gathers its own data from providers and does not describe a risk adjustment methodology. Risk adjustment is important because the lack of risk adjustment may lead to physicians “cherry-picking” easy cases to boost positive outcomes, leading to increased financial benefits and higher quality ratings. Having a consistent risk adjustment formula will ensure accurate comparisons across outcomes and cost-effectiveness measures used by quality designation programs.

Factors considered for quality designation varied greatly from one organization to the other. The range of categories of factors considered varied from 1 (Consumer Reports only considered outcome data) to all 7 categories (BCBS Distinction+ and Aetna Institutes of Quality for Orthopedic Surgery). Our findings are consistent with the work by Keswani and colleagues,⁸ which showed that there is likely variation in factors considered when rating hospital quality more broadly. Our work suggests that quality designation formulas do not appear to get more consistent when focused on TJA.

We found that all organizations in our analysis published the providers earning their quality designation. However, TJC does not provide publicly a detailed methodology on how to qualify for its quality designation. The price to purchase the necessary manual for this information is $146.00 for accredited organizations and $186.00 for all others.¹⁷ For large healthcare providers, this is not a large sum of money. Nonetheless, this provides an additional hurdle for stakeholders to gain a full understanding of the requirements to receive a TJC Gold Seal for Orthopedics.

Previous work has evaluated the consistency of and the variety of means of gauging healthcare quality. Previous work by Rothberg and colleagues¹⁸ comparing hospital rankings across 5 common consumer-oriented websites found disagreement on hospital rankings within any diagnosis and even among metrics such as mortality. Another study by Halasyamani and Davis¹⁹ found that CMS Compare and USNWR rankings were dissimilar and the authors attributed the discrepancy to different methodologies. In addition, a study by Krumholz and colleagues²⁰ focused on Internet report cards, which measured the appropriate use of select medications and mortality rates for acute myocardial infarction as the quality metrics. The authors found that, in aggregate, there was a clear difference in quality of care and outcomes but that comparisons between 2 hospitals provided poor discrimination.²⁰ Other work has analyzed the increasing trend of online ratings of orthopedic surgeons by patients.²¹ However, there remains no agreed-upon definition of quality. Thus, the use of the term “quality” in several studies may be misleading.

Our results must be interpreted keeping the limitations of our work in mind. First, we used expert knowledge and a public search engine to develop our list of organizations that provide TJA quality designations. However, there is a possibility that we did not include all relevant organizations. Second, although all authors reviewed the final data, it is possible that there was human error in the analysis of each organization’s quality designation criteria.

CONCLUSION

As healthcare progresses further toward a system that rewards providers for delivering value to patients, accurately defining and measuring quality becomes critical because it can be suggestive of value to patients, payers, and providers. Furthermore, it gives providers a goal to focus on as they strive to improve the value of care they deliver to patients. Measuring healthcare quality is currently a novel, imperfect science,²² and there continues to be a debate about what factors should be included in a quality designation formula. Nonetheless, more and more quality designations and performance measurements are being created for orthopedic care, including total hip and total knee arthroplasty. In fact, in 2016, The Leapfrog Group added readmission for patients undergoing TJA to its survey.²³ Consensus on a quality definition may facilitate the movement toward a value-based healthcare system. Future research should evaluate strategies for gaining consensus among stakeholders for a universal quality metric in TJA. Surgeons, hospitals, payers, and most importantly patients should play critical roles in defining quality.

ABSTRACT

Osteoarthritis (OA) of the knee is a top cause of disability among the elderly. Total knee replacement (TKR) has been available as an effective and definite surgical method to treat severe OA of the knee. However, TKR is a significant procedure with potential risk for serious complications and high costs. Alternative lower risk therapies that can delay or obviate TKR are valuable to those who are poor candidates for surgery or wish to avoid TKR as long as possible. Given the chondroprotective effects of hyaluronic acid (HA) injections, they are a safe and effective treatment to improve pain, function, and longevity of the knee. Thus, HA features the potential to delay or obviate TKR.

We aim to study the safety and effectiveness of repeated courses of HA on the time to TKR over a 3-year period using data from a large US health plan administrative claims database.

Retrospective analyses were conducted by identifying knee OA patients during the selection period (2007-2010). The follow-up period was 36 months, post-index date of initial HA injection. Procedural outcomes and adverse events of interest were tabulated and analyzed. A Cox proportional hazards model was used to model the risk of TKR.

A total of 50,389 patients who received HA for treatment of knee OA and met the study inclusion criteria were analyzed. Successive courses of HA showed a good safety profile and led to high proportions of patients without TKR 3 years after treatment initiation. Multivariate statistical modeling showed that multiple courses of HA injections significantly decreased the rates of TKR (95.0% without TKR for ≥5 courses vs 71.6% without TKR for 1 course; hazard ratio, 0.138; P < .0001).

Repeated courses of treatment with HA are safe and are associated with the delay of TKR for up to 3 years. Additional research is needed to evaluate the effect of repeated HA courses on delaying TKR beyond a 3-year time horizon.

Continue to: Osteoarthritis (OA) of the knee...

Osteoarthritis (OA) of the knee has emerged as one of the main causes of disability in the United States. Although no currently known cure of OA can reverse the progression of the disease, total knee replacement (TKR) is an effective and definitive treatment. However, TKR is an invasive procedure with potential risk for serious complications, and it has imposed high costs on the US healthcare system, with expenses accounting for hospital expenditures of TKR estimated at $28.5 billion in 2009.¹Alternative low-risk therapies that can delay or obviate TKR are valuable to a number of patients, especially the poor candidates for surgery or those who wish to avoid TKR.

Intra-articular (IA) hyaluronic acid (HA) injections have been available as a safe and effective treatment option to alleviate pain and to improve joint functions.² Results of randomized double-blind controlled clinical trials have demonstrated the pain-relieving effect of IA HA injections.^3-5 Furthermore, a recent network meta-analysis comparing various pharmacologic interventions for knee OA has confirmed the efficacy of IA HA injections, which outperformed other interventions when compared with oral placebos.^6,7 IA therapies are more effective than oral therapies for knee OA pain, with IA HA injections demonstrating the most pain reduction, potentially due to the benefit associated with needle injection and aspiration. Recent experimental studies have also suggested that IA HA may provide cartilage protection, reduce inflammation, and boost the viscosity of synovial fluid;⁸ IA HA may also exert therapeutic effects by inhibiting bone formation in OA patients.^9,10 HA possesses the potential to delay or obviate TKR. Previous research with a case series review of patients in an orthopedic specialty practice reported that the use of IA HA injections in patients with grade IV OA delayed TKR substantially.¹¹ One study analyzed retrospective medical claims data from a single private insurer and discovered potential evidence for the modest benefit of IA HA injections in delaying TKR.¹²

More detailed research work on a large sample of patients with knee OA and the requirement of TKR as a condition for inclusion using US administrative claims data has demonstrated the TKR-delaying effects of IA HA injections in comparison with a control group without claims for IA HA injections.^13,14 This study also uses real-world US administrative data but utilizes a different approach by starting with a sample of patients with knee OA and evidence of IA HA injections and then assessing the effect of repeated courses of HA treatment on the delay of TKR, without TKR as a mandatory condition for inclusion. All patients with knee OA within the time window were included, regardless of the need for TKR compared with previous studies which only considered patients who ultimately received TKR. Safety information and effectiveness information were examined to achieve a balanced risk-benefit assessment. We also analyzed how multiple courses of HA treatment and other potentially relevant covariates at baseline affected the risk of receiving TKR in a multivariate survival model. We aimed to achieve a realistic assessment of the clinical utility of HA injections in delaying TKR in a real-world setting using both safety and effectiveness data.

METHODS

DATA SOURCE

A retrospective cohort observational study using IMS Health’s PharMetrics Plus Health Plan Claims Database was conducted by identifying knee OA patients with claims indicating initiation of HA injection at an index date during the selection period (July 1, 2007 to June 30, 2010). All common HA agents in the US market during this period (Euflexxa, Hyalgan, Orthovisc, Supartz, and Synvisc) were selected via the corresponding J-codes and pooled for investigation of HA class effects. The follow-up period was 36 months, post-index date of the initial HA injection. Outcomes were measured, and adverse events were identified during this period. The time window for identification of adverse events was within 2 weeks from any injection during the course of therapy (evidence of an emergency room visit and/or physician office visit with requisite code). The data during the 12-month pre-index baseline period from the claims database was used to obtain information about baseline patient characteristics, such as age, gender, type of coverage, physician specialty, Charlson Comorbidity Index (CCI), major comorbidities, and major medications of interest commonly used among patients with knee OA.

STUDY SAMPLE SELECTION

The eligible patients required an outpatient claim indicating the initiation of HA injection. The date of the first claim for the patient within the selection window was defined as their index date. Patients had to be ≥18 years of age in the year of their index date. They had to present at least 1 clinical knee OA diagnosis at any point in the 12-month pre-index period (including the index date), and only patients who were continuously enrolled from 12 months pre-index to 36 months post-index date were evaluated. Among these patients (approximately 1.4 million), the following were excluded to minimize complications in data analysis and interpretation: patients with evidence of any HA use in the pre-index period; patients with evidence of a different kind of HA index medication in the post-index period; patients with evidence of TKR within 30 days of the index event during the post-index period; patients with evidence of 2 different kinds of HA index medications on the index date; and patients with evidence of diagnosis of hip OA, fibromyalgia, rheumatoid arthritis, lupus, or gout during the pre-index period.

Five patient cohorts were defined according to the number of courses of IA HA injections over the entire post-index period.

Continue to: Statistical analysis...

STATISTICAL ANALYSIS

All statistical analyses were performed using SAS version 9.2 (SAS Institute Inc.). Descriptive statistics such as means, standard deviations, medians, and 25% and 75% percentiles (Q1 and Q3, respectively) were provided for the continuous variables. Numbers and percentages were provided for the categorical variables. For statistical testing, Student’s t-tests were applied for the continuous variables and chi-square tests for the categorical variables. All the statistical tests were two-tailed. The sample sizes in this database study are remarkably large, such that differences that are not clinically important could still be statistically significant at the conventional alpha level of 0.05. Thus, we applied a more stringent requirement of the alpha level of 0.0001 to identify highly statistically significant results. The number and percentage of patients within each cohort with at least 1 instance of an adverse event of interest (those adverse events commonly expected for patients who receive IA injections for knee OA) were assessed. Times to TKR during the 36-month post-index period were analyzed and compared among different cohorts. Any patients who had not undergone TKR by the end of the post-index period were considered censored at 36 months. The Kaplan-Meier method was employed to model survival curves with time to TKR data, and log-rank tests were used to compare survival curves among different cohorts. A Cox proportional hazards model (PHM) was used to model the risk of TKR with a pre-specified set of covariates adjusted for baseline attributes, such as age, gender, comorbidities, and pre-index healthcare costs. Hazard ratios with 95% confidence intervals were used to examine the measures of event risk.

RESULTS

PATIENT CHARACTERISTICS

Applying study selection criteria to the claims database yielded 50,389 patients (Figure 1), providing an ample sample size for the statistical analysis. Only patients with evidence of knee OA and use of HA injections (the index medication of interest) were selected, regardless of whether they received TKR during the post-index period. The requirement for a knee OA diagnosis during the 12-month pre-index period resulted in the significant attrition of patients, with 584,956 patients being excluded. Among the 50,389 patients who received HA for treatment of knee OA, 36,260 (72.0%) received a single course of treatment, 8709 (17.3%) received 2 courses, 3179 (6.3%) received 3 courses, 1354 (2.7%) received 4 courses, and 887 (1.8%) received ≥5 courses of treatment.

Comparison of baseline characteristics among the 5 IA HA cohorts showed the fairly similar baseline characteristics of all cohorts (Table 1). Geographic region, physician specialty, and opioid use showed differences among the cohorts. Cohorts with ≥5 HA courses presented lower proportions of patients from Southern US states, patients seeing orthopedic surgeons, and patients using opioids than cohorts with fewer HA courses.

PROCEDURES OF INTEREST

An analysis of the procedures patients received after HA treatment initiation showed that higher numbers of HA treatment courses resulted in lower proportions of patients receiving TKR within 3 years after HA treatment initiation (Table 2). With an increasing number of HA treatment courses, the proportion of patients with TKR within 3 years post-index consistently decreased from 28.4% (for 1 HA course) to 5.0% (for ≥5 HA courses), with all differences being highly statistically significant (P < .0001). Similarly, partial knee replacement exhibited a similar trend, with the proportion of patients decreasing from 3.3% (for 1 HA course) to 0.8% (for ≥5 HA courses; P < .0001). Among the patients with TKR within 3 years post-index, increasing numbers of treatment courses correlated with increasing time to TKR, with a mean of 375.6 days (for 1 HA course) rising to a mean of 971.5 days (for ≥5 HA courses; P < .0001). On the other hand, patients with multiple courses of HA treatment were more likely to undergo radiologic examinations of the knee, arthrocenteses, and image-guided injections than patients with only a single course of HA treatment (P < .0001).

ADVERSE EVENTS

Arthralgia and joint pain in the knee were the most commonly recorded adverse events (Table 3). More courses of HA treatment were associated with higher rates of adverse events. Overall, the reported adverse events profile of repeated courses of HA treatment consisted of mostly common and mild adverse events and displayed no safety concern for patients with knee OA that was followed-up for 3 years. The causality of these adverse events directly related to HA injections vs a specific disease state cannot be determined from an administrative claims data set.

TIME TO TKR

Successive courses of HA led to high proportions of patients without TKR 3 years after HA treatment initiation. This result is evident in the Kaplan-Meier survival curves of time to TKR for different HA cohorts (Figure 2), with log-rank tests of multiple courses vs a single course of HA (P < .0001) showing highly statistically significance. Tabulation of proportions of patients without TKR by various time points showed that increasing numbers of HA treatment courses correlated with higher proportions of patients without TKR at almost all time points (Table 4); within 3 years post-index, 71.6% of patients in the 1 HA course cohort exhibited no TKR, whereas 95.0% of patients in ≥5 HA courses cohort presented no TKR. We also performed a multivariate Cox PHM (Table 5) to account for baseline characteristics of different HA cohorts with covariates when estimating the risks of receiving TKR. The results of the Cox PHM showed that multiple courses of HA treatment significantly decreased the risk of TKR (hazard ratio, 0.138 for ≥5 HA courses vs 1 HA course; P < .0001). Inspection of other highly significant covariates showed that being older, living in the Midwest region of the US (vs the Northeast), receiving pre-index corticosteroids, having an orthopedic surgeon as a treating physician (vs a general practitioner, a rheumatologist, or a physical medicine and rehabilitation specialist), experiencing hypertension or hyperlipidemia, and higher pre-index total healthcare costs were associated with an increased risk of TKR (all P < .0001). Vascular disease and high CCI scores were associated with a decreased risk of TKR (P < .0001).

Continue to: Discussion...

DISCUSSION

This study demonstrated that multiple courses of HA treatment can delay the need for surgery for up to 3 years, with risk for both TKR and partial knee replacement decreasing in a dose-dependent manner. The potentially confounding effect of differences in baseline characteristics that could influence patients’ propensity to receive TKR in a database study was controlled by performing a multivariate analysis with covariate adjustment. The TKR-delaying effect of HA injection was more prominent in cohorts with a high number of HA treatment courses: 19 out of 20 patients in the cohort of ≥5 HA courses were free of TKR at the end of the 3-year post-index period. Such a high proportion of patients avoiding TKR with repeated courses of HA suggests that some patients may be able to successfully delay TKR well beyond the 3-year time span. This finding is counter-evidence to the frequently made assumption¹⁵ that all patients with knee OA will eventually progress to a state of disability, making TKR inevitable. The patients with end-stage radiographic knee OA can also benefit from IA HA injections for an extended period of time;¹⁶ the latest evidence indicates that nonoperative management can improve symptoms irrespective of radiographic disease severity, implying that TKR needs not to be the only therapeutic option for patients with end-stage radiographic knee OA.¹⁷ This finding suggests that HA treatment should be considered an important clinical treatment option for patients with knee OA.

Although the incidence rates of certain adverse events, such as arthralgia/joint pain, are sizable, these temporary adverse events commonly occur among patients who receive IA injections for knee OA; most of these events may simply include symptoms of the remaining underlying knee OA. These results are consistent with those of previous literature reporting the safety of repeated treatment with IA HA injections in a prospective clinical trial¹⁸ and demonstrating that repeated courses of HA treatment pose no greater safety risk than a single course of HA treatment.

Multivariate modeling outcomes of factors influencing risk of receiving TKR are broadly consistent with the generally accepted notions that different levels of disease severity and patients’ willingness to consider TKR at baseline influence the likelihood and timing of receiving TKR.^19,20 Age and obesity are common risk factors for progression of OA. Orthopedic surgeons are more likely to recommend surgery than non-surgeons. The pre-index use of corticosteroids and high pre-index healthcare costs could be associated with more severe symptoms at baseline. Patients with vascular disease or severe comorbidities, as evidenced by high CCI scores, make poor candidates for major elective surgeries such as TKR. These results are intuitive and validate the clinical insights of this study. Moreover, inclusion of these covariates in the analysis model allows for indirect adjustment of the most important prognostic factors for TKR at baseline, permitting proper statistical comparison of the results for different cohort groups.

Recently, the efficacy of HA injections for OA patients has become the subject of debate when the American Academy of Orthopaedic Surgeons (AAOS) revised its clinical practice guideline, recommending against the use of HA.²¹ The AAOS’ findings differ from those of other clinical societies, such as the American College of Rheumatology²² and the European League Against Rheumatism,²³ which provide no strong recommendation against the use of HA injections. The announcement of the new guideline by AAOS caused concern among clinicians and payers who had valued IA HA injections as a means to control knee OA pain before patients progress to TKR;²⁴ on the other hand, the demand for nonoperative treatment of knee OA remains high. Utilization rates of TKR have increased dramatically, and surgeries are now performed on younger patients with increasing burden on the healthcare system,^25,26 in spite of the fact that as high as a third of TKR surgeries may have been performed in inappropriate patients.²⁷ Part of the confusion surrounding clinical utility of HA stems from the fact that up until recently, relatively little research looked into the practical benefits of HA in actual clinical practice. Analyses of databases such as registries are now gaining attention to overcome that problem. Examination of large administrative databases maintained by commercial payers offers the benefit of probing realistically the safety and efficacy of treatments in actual clinical environments in a very large number of patients with heterogeneous backgrounds. Recently, the Agency for Healthcare Research and Quality’s Technology Assessment Program in the US called for such studies to determine whether HA injections can delay progression to TKR.²⁸ The results of this study and several others^11,13,14,16 suggest that use of HA to treat OA of the knee is associated with the delay of TKR, supporting the utility of HA in clinical practice and the healthcare system. Potential clinical benefits of delaying TKR may include the reduced risk of aseptic loosening if younger patients can wait for TKR or more time to allow the modification of risk factors in patients who will ultimately undergo TKR.

LIMITATIONS

Follow-up period was limited to 3 years post-index date because longer follow-up data were not available at the time of the study design. If an incorrect adverse event or OA diagnosis was listed in the medical record, or if the medical record was incomplete, then patients might have been misclassified, resulting in selection bias. The claims dataset includes no uninsured and Medicare patients, as the population in the database consisted primarily of commercially-insured patients in the US. Therefore, the results are most generalizable to other commercially-insured patients in the US. Generalizability to other populations may not be assured if they differ in their accessibility to physician services or prescriptions from the patients in this study. Other treatments such as the nonsteroidal anti-inflammatory drugs used by patients were not included within the pre-specified statistical model because their potential effects were assumed to be short-lived and much less than those of corticosteroid. Including these treatments would overload the statistical model with too many covariates, leading to potential computational instability. The database used provides no information on systemic factors, including plan limits on medication use, that could affect care. Given the large and diverse nature of the healthcare plans in the database. However, these factors should not have materially affected our study results. The claims database also lacks direct indicators of OA disease severity, such as Kellgren-Lawrence scores or patient-reported outcomes, including pain and function questionnaire scores. Our multivariate analysis indirectly makes up for this deficiency by considering other baseline characteristics or clinical indicators that may be correlated with information unavailable in a claims database. Patients who opt to undergo repeated courses of HA treatment may be more inclined to avoid surgery or may naturally experience OA disease progression more slowly, making them potentially different from patients who select to undergo surgery earlier without repeated courses of HA treatment. This condition may introduce a bias that causes difficulty in proving the causality between repeated HA use and delay of TKR.

CONCLUSION

Analysis of the knee OA patient data from a real-world database showed that repeated courses of treatment with HA are safe and are associated with the delay of TKR for up to 3 years. Additional research is needed to evaluate the effects of repeated HA courses on delaying TKR beyond a 3-year period.

ABSTRACT

Osteoarthritis (OA) of the knee is a top cause of disability among the elderly. Total knee replacement (TKR) has been available as an effective and definite surgical method to treat severe OA of the knee. However, TKR is a significant procedure with potential risk for serious complications and high costs. Alternative lower risk therapies that can delay or obviate TKR are valuable to those who are poor candidates for surgery or wish to avoid TKR as long as possible. Given the chondroprotective effects of hyaluronic acid (HA) injections, they are a safe and effective treatment to improve pain, function, and longevity of the knee. Thus, HA features the potential to delay or obviate TKR.

We aim to study the safety and effectiveness of repeated courses of HA on the time to TKR over a 3-year period using data from a large US health plan administrative claims database.

Retrospective analyses were conducted by identifying knee OA patients during the selection period (2007-2010). The follow-up period was 36 months, post-index date of initial HA injection. Procedural outcomes and adverse events of interest were tabulated and analyzed. A Cox proportional hazards model was used to model the risk of TKR.

A total of 50,389 patients who received HA for treatment of knee OA and met the study inclusion criteria were analyzed. Successive courses of HA showed a good safety profile and led to high proportions of patients without TKR 3 years after treatment initiation. Multivariate statistical modeling showed that multiple courses of HA injections significantly decreased the rates of TKR (95.0% without TKR for ≥5 courses vs 71.6% without TKR for 1 course; hazard ratio, 0.138; P < .0001).

Repeated courses of treatment with HA are safe and are associated with the delay of TKR for up to 3 years. Additional research is needed to evaluate the effect of repeated HA courses on delaying TKR beyond a 3-year time horizon.

Continue to: Osteoarthritis (OA) of the knee...

Osteoarthritis (OA) of the knee has emerged as one of the main causes of disability in the United States. Although no currently known cure of OA can reverse the progression of the disease, total knee replacement (TKR) is an effective and definitive treatment. However, TKR is an invasive procedure with potential risk for serious complications, and it has imposed high costs on the US healthcare system, with expenses accounting for hospital expenditures of TKR estimated at $28.5 billion in 2009.¹Alternative low-risk therapies that can delay or obviate TKR are valuable to a number of patients, especially the poor candidates for surgery or those who wish to avoid TKR.

Intra-articular (IA) hyaluronic acid (HA) injections have been available as a safe and effective treatment option to alleviate pain and to improve joint functions.² Results of randomized double-blind controlled clinical trials have demonstrated the pain-relieving effect of IA HA injections.^3-5 Furthermore, a recent network meta-analysis comparing various pharmacologic interventions for knee OA has confirmed the efficacy of IA HA injections, which outperformed other interventions when compared with oral placebos.^6,7 IA therapies are more effective than oral therapies for knee OA pain, with IA HA injections demonstrating the most pain reduction, potentially due to the benefit associated with needle injection and aspiration. Recent experimental studies have also suggested that IA HA may provide cartilage protection, reduce inflammation, and boost the viscosity of synovial fluid;⁸ IA HA may also exert therapeutic effects by inhibiting bone formation in OA patients.^9,10 HA possesses the potential to delay or obviate TKR. Previous research with a case series review of patients in an orthopedic specialty practice reported that the use of IA HA injections in patients with grade IV OA delayed TKR substantially.¹¹ One study analyzed retrospective medical claims data from a single private insurer and discovered potential evidence for the modest benefit of IA HA injections in delaying TKR.¹²

More detailed research work on a large sample of patients with knee OA and the requirement of TKR as a condition for inclusion using US administrative claims data has demonstrated the TKR-delaying effects of IA HA injections in comparison with a control group without claims for IA HA injections.^13,14 This study also uses real-world US administrative data but utilizes a different approach by starting with a sample of patients with knee OA and evidence of IA HA injections and then assessing the effect of repeated courses of HA treatment on the delay of TKR, without TKR as a mandatory condition for inclusion. All patients with knee OA within the time window were included, regardless of the need for TKR compared with previous studies which only considered patients who ultimately received TKR. Safety information and effectiveness information were examined to achieve a balanced risk-benefit assessment. We also analyzed how multiple courses of HA treatment and other potentially relevant covariates at baseline affected the risk of receiving TKR in a multivariate survival model. We aimed to achieve a realistic assessment of the clinical utility of HA injections in delaying TKR in a real-world setting using both safety and effectiveness data.

METHODS

DATA SOURCE

A retrospective cohort observational study using IMS Health’s PharMetrics Plus Health Plan Claims Database was conducted by identifying knee OA patients with claims indicating initiation of HA injection at an index date during the selection period (July 1, 2007 to June 30, 2010). All common HA agents in the US market during this period (Euflexxa, Hyalgan, Orthovisc, Supartz, and Synvisc) were selected via the corresponding J-codes and pooled for investigation of HA class effects. The follow-up period was 36 months, post-index date of the initial HA injection. Outcomes were measured, and adverse events were identified during this period. The time window for identification of adverse events was within 2 weeks from any injection during the course of therapy (evidence of an emergency room visit and/or physician office visit with requisite code). The data during the 12-month pre-index baseline period from the claims database was used to obtain information about baseline patient characteristics, such as age, gender, type of coverage, physician specialty, Charlson Comorbidity Index (CCI), major comorbidities, and major medications of interest commonly used among patients with knee OA.

STUDY SAMPLE SELECTION

The eligible patients required an outpatient claim indicating the initiation of HA injection. The date of the first claim for the patient within the selection window was defined as their index date. Patients had to be ≥18 years of age in the year of their index date. They had to present at least 1 clinical knee OA diagnosis at any point in the 12-month pre-index period (including the index date), and only patients who were continuously enrolled from 12 months pre-index to 36 months post-index date were evaluated. Among these patients (approximately 1.4 million), the following were excluded to minimize complications in data analysis and interpretation: patients with evidence of any HA use in the pre-index period; patients with evidence of a different kind of HA index medication in the post-index period; patients with evidence of TKR within 30 days of the index event during the post-index period; patients with evidence of 2 different kinds of HA index medications on the index date; and patients with evidence of diagnosis of hip OA, fibromyalgia, rheumatoid arthritis, lupus, or gout during the pre-index period.

Five patient cohorts were defined according to the number of courses of IA HA injections over the entire post-index period.

Continue to: Statistical analysis...

STATISTICAL ANALYSIS

All statistical analyses were performed using SAS version 9.2 (SAS Institute Inc.). Descriptive statistics such as means, standard deviations, medians, and 25% and 75% percentiles (Q1 and Q3, respectively) were provided for the continuous variables. Numbers and percentages were provided for the categorical variables. For statistical testing, Student’s t-tests were applied for the continuous variables and chi-square tests for the categorical variables. All the statistical tests were two-tailed. The sample sizes in this database study are remarkably large, such that differences that are not clinically important could still be statistically significant at the conventional alpha level of 0.05. Thus, we applied a more stringent requirement of the alpha level of 0.0001 to identify highly statistically significant results. The number and percentage of patients within each cohort with at least 1 instance of an adverse event of interest (those adverse events commonly expected for patients who receive IA injections for knee OA) were assessed. Times to TKR during the 36-month post-index period were analyzed and compared among different cohorts. Any patients who had not undergone TKR by the end of the post-index period were considered censored at 36 months. The Kaplan-Meier method was employed to model survival curves with time to TKR data, and log-rank tests were used to compare survival curves among different cohorts. A Cox proportional hazards model (PHM) was used to model the risk of TKR with a pre-specified set of covariates adjusted for baseline attributes, such as age, gender, comorbidities, and pre-index healthcare costs. Hazard ratios with 95% confidence intervals were used to examine the measures of event risk.

RESULTS

PATIENT CHARACTERISTICS

Applying study selection criteria to the claims database yielded 50,389 patients (Figure 1), providing an ample sample size for the statistical analysis. Only patients with evidence of knee OA and use of HA injections (the index medication of interest) were selected, regardless of whether they received TKR during the post-index period. The requirement for a knee OA diagnosis during the 12-month pre-index period resulted in the significant attrition of patients, with 584,956 patients being excluded. Among the 50,389 patients who received HA for treatment of knee OA, 36,260 (72.0%) received a single course of treatment, 8709 (17.3%) received 2 courses, 3179 (6.3%) received 3 courses, 1354 (2.7%) received 4 courses, and 887 (1.8%) received ≥5 courses of treatment.

Comparison of baseline characteristics among the 5 IA HA cohorts showed the fairly similar baseline characteristics of all cohorts (Table 1). Geographic region, physician specialty, and opioid use showed differences among the cohorts. Cohorts with ≥5 HA courses presented lower proportions of patients from Southern US states, patients seeing orthopedic surgeons, and patients using opioids than cohorts with fewer HA courses.

PROCEDURES OF INTEREST

An analysis of the procedures patients received after HA treatment initiation showed that higher numbers of HA treatment courses resulted in lower proportions of patients receiving TKR within 3 years after HA treatment initiation (Table 2). With an increasing number of HA treatment courses, the proportion of patients with TKR within 3 years post-index consistently decreased from 28.4% (for 1 HA course) to 5.0% (for ≥5 HA courses), with all differences being highly statistically significant (P < .0001). Similarly, partial knee replacement exhibited a similar trend, with the proportion of patients decreasing from 3.3% (for 1 HA course) to 0.8% (for ≥5 HA courses; P < .0001). Among the patients with TKR within 3 years post-index, increasing numbers of treatment courses correlated with increasing time to TKR, with a mean of 375.6 days (for 1 HA course) rising to a mean of 971.5 days (for ≥5 HA courses; P < .0001). On the other hand, patients with multiple courses of HA treatment were more likely to undergo radiologic examinations of the knee, arthrocenteses, and image-guided injections than patients with only a single course of HA treatment (P < .0001).

ADVERSE EVENTS

Arthralgia and joint pain in the knee were the most commonly recorded adverse events (Table 3). More courses of HA treatment were associated with higher rates of adverse events. Overall, the reported adverse events profile of repeated courses of HA treatment consisted of mostly common and mild adverse events and displayed no safety concern for patients with knee OA that was followed-up for 3 years. The causality of these adverse events directly related to HA injections vs a specific disease state cannot be determined from an administrative claims data set.

TIME TO TKR

Successive courses of HA led to high proportions of patients without TKR 3 years after HA treatment initiation. This result is evident in the Kaplan-Meier survival curves of time to TKR for different HA cohorts (Figure 2), with log-rank tests of multiple courses vs a single course of HA (P < .0001) showing highly statistically significance. Tabulation of proportions of patients without TKR by various time points showed that increasing numbers of HA treatment courses correlated with higher proportions of patients without TKR at almost all time points (Table 4); within 3 years post-index, 71.6% of patients in the 1 HA course cohort exhibited no TKR, whereas 95.0% of patients in ≥5 HA courses cohort presented no TKR. We also performed a multivariate Cox PHM (Table 5) to account for baseline characteristics of different HA cohorts with covariates when estimating the risks of receiving TKR. The results of the Cox PHM showed that multiple courses of HA treatment significantly decreased the risk of TKR (hazard ratio, 0.138 for ≥5 HA courses vs 1 HA course; P < .0001). Inspection of other highly significant covariates showed that being older, living in the Midwest region of the US (vs the Northeast), receiving pre-index corticosteroids, having an orthopedic surgeon as a treating physician (vs a general practitioner, a rheumatologist, or a physical medicine and rehabilitation specialist), experiencing hypertension or hyperlipidemia, and higher pre-index total healthcare costs were associated with an increased risk of TKR (all P < .0001). Vascular disease and high CCI scores were associated with a decreased risk of TKR (P < .0001).

Continue to: Discussion...

DISCUSSION

This study demonstrated that multiple courses of HA treatment can delay the need for surgery for up to 3 years, with risk for both TKR and partial knee replacement decreasing in a dose-dependent manner. The potentially confounding effect of differences in baseline characteristics that could influence patients’ propensity to receive TKR in a database study was controlled by performing a multivariate analysis with covariate adjustment. The TKR-delaying effect of HA injection was more prominent in cohorts with a high number of HA treatment courses: 19 out of 20 patients in the cohort of ≥5 HA courses were free of TKR at the end of the 3-year post-index period. Such a high proportion of patients avoiding TKR with repeated courses of HA suggests that some patients may be able to successfully delay TKR well beyond the 3-year time span. This finding is counter-evidence to the frequently made assumption¹⁵ that all patients with knee OA will eventually progress to a state of disability, making TKR inevitable. The patients with end-stage radiographic knee OA can also benefit from IA HA injections for an extended period of time;¹⁶ the latest evidence indicates that nonoperative management can improve symptoms irrespective of radiographic disease severity, implying that TKR needs not to be the only therapeutic option for patients with end-stage radiographic knee OA.¹⁷ This finding suggests that HA treatment should be considered an important clinical treatment option for patients with knee OA.

Although the incidence rates of certain adverse events, such as arthralgia/joint pain, are sizable, these temporary adverse events commonly occur among patients who receive IA injections for knee OA; most of these events may simply include symptoms of the remaining underlying knee OA. These results are consistent with those of previous literature reporting the safety of repeated treatment with IA HA injections in a prospective clinical trial¹⁸ and demonstrating that repeated courses of HA treatment pose no greater safety risk than a single course of HA treatment.

Multivariate modeling outcomes of factors influencing risk of receiving TKR are broadly consistent with the generally accepted notions that different levels of disease severity and patients’ willingness to consider TKR at baseline influence the likelihood and timing of receiving TKR.^19,20 Age and obesity are common risk factors for progression of OA. Orthopedic surgeons are more likely to recommend surgery than non-surgeons. The pre-index use of corticosteroids and high pre-index healthcare costs could be associated with more severe symptoms at baseline. Patients with vascular disease or severe comorbidities, as evidenced by high CCI scores, make poor candidates for major elective surgeries such as TKR. These results are intuitive and validate the clinical insights of this study. Moreover, inclusion of these covariates in the analysis model allows for indirect adjustment of the most important prognostic factors for TKR at baseline, permitting proper statistical comparison of the results for different cohort groups.

Recently, the efficacy of HA injections for OA patients has become the subject of debate when the American Academy of Orthopaedic Surgeons (AAOS) revised its clinical practice guideline, recommending against the use of HA.²¹ The AAOS’ findings differ from those of other clinical societies, such as the American College of Rheumatology²² and the European League Against Rheumatism,²³ which provide no strong recommendation against the use of HA injections. The announcement of the new guideline by AAOS caused concern among clinicians and payers who had valued IA HA injections as a means to control knee OA pain before patients progress to TKR;²⁴ on the other hand, the demand for nonoperative treatment of knee OA remains high. Utilization rates of TKR have increased dramatically, and surgeries are now performed on younger patients with increasing burden on the healthcare system,^25,26 in spite of the fact that as high as a third of TKR surgeries may have been performed in inappropriate patients.²⁷ Part of the confusion surrounding clinical utility of HA stems from the fact that up until recently, relatively little research looked into the practical benefits of HA in actual clinical practice. Analyses of databases such as registries are now gaining attention to overcome that problem. Examination of large administrative databases maintained by commercial payers offers the benefit of probing realistically the safety and efficacy of treatments in actual clinical environments in a very large number of patients with heterogeneous backgrounds. Recently, the Agency for Healthcare Research and Quality’s Technology Assessment Program in the US called for such studies to determine whether HA injections can delay progression to TKR.²⁸ The results of this study and several others^11,13,14,16 suggest that use of HA to treat OA of the knee is associated with the delay of TKR, supporting the utility of HA in clinical practice and the healthcare system. Potential clinical benefits of delaying TKR may include the reduced risk of aseptic loosening if younger patients can wait for TKR or more time to allow the modification of risk factors in patients who will ultimately undergo TKR.

LIMITATIONS

Follow-up period was limited to 3 years post-index date because longer follow-up data were not available at the time of the study design. If an incorrect adverse event or OA diagnosis was listed in the medical record, or if the medical record was incomplete, then patients might have been misclassified, resulting in selection bias. The claims dataset includes no uninsured and Medicare patients, as the population in the database consisted primarily of commercially-insured patients in the US. Therefore, the results are most generalizable to other commercially-insured patients in the US. Generalizability to other populations may not be assured if they differ in their accessibility to physician services or prescriptions from the patients in this study. Other treatments such as the nonsteroidal anti-inflammatory drugs used by patients were not included within the pre-specified statistical model because their potential effects were assumed to be short-lived and much less than those of corticosteroid. Including these treatments would overload the statistical model with too many covariates, leading to potential computational instability. The database used provides no information on systemic factors, including plan limits on medication use, that could affect care. Given the large and diverse nature of the healthcare plans in the database. However, these factors should not have materially affected our study results. The claims database also lacks direct indicators of OA disease severity, such as Kellgren-Lawrence scores or patient-reported outcomes, including pain and function questionnaire scores. Our multivariate analysis indirectly makes up for this deficiency by considering other baseline characteristics or clinical indicators that may be correlated with information unavailable in a claims database. Patients who opt to undergo repeated courses of HA treatment may be more inclined to avoid surgery or may naturally experience OA disease progression more slowly, making them potentially different from patients who select to undergo surgery earlier without repeated courses of HA treatment. This condition may introduce a bias that causes difficulty in proving the causality between repeated HA use and delay of TKR.

CONCLUSION

Analysis of the knee OA patient data from a real-world database showed that repeated courses of treatment with HA are safe and are associated with the delay of TKR for up to 3 years. Additional research is needed to evaluate the effects of repeated HA courses on delaying TKR beyond a 3-year period.

ABSTRACT

Osteoarthritis (OA) of the knee is a top cause of disability among the elderly. Total knee replacement (TKR) has been available as an effective and definite surgical method to treat severe OA of the knee. However, TKR is a significant procedure with potential risk for serious complications and high costs. Alternative lower risk therapies that can delay or obviate TKR are valuable to those who are poor candidates for surgery or wish to avoid TKR as long as possible. Given the chondroprotective effects of hyaluronic acid (HA) injections, they are a safe and effective treatment to improve pain, function, and longevity of the knee. Thus, HA features the potential to delay or obviate TKR.

We aim to study the safety and effectiveness of repeated courses of HA on the time to TKR over a 3-year period using data from a large US health plan administrative claims database.

Retrospective analyses were conducted by identifying knee OA patients during the selection period (2007-2010). The follow-up period was 36 months, post-index date of initial HA injection. Procedural outcomes and adverse events of interest were tabulated and analyzed. A Cox proportional hazards model was used to model the risk of TKR.

A total of 50,389 patients who received HA for treatment of knee OA and met the study inclusion criteria were analyzed. Successive courses of HA showed a good safety profile and led to high proportions of patients without TKR 3 years after treatment initiation. Multivariate statistical modeling showed that multiple courses of HA injections significantly decreased the rates of TKR (95.0% without TKR for ≥5 courses vs 71.6% without TKR for 1 course; hazard ratio, 0.138; P < .0001).

Repeated courses of treatment with HA are safe and are associated with the delay of TKR for up to 3 years. Additional research is needed to evaluate the effect of repeated HA courses on delaying TKR beyond a 3-year time horizon.

Continue to: Osteoarthritis (OA) of the knee...

Osteoarthritis (OA) of the knee has emerged as one of the main causes of disability in the United States. Although no currently known cure of OA can reverse the progression of the disease, total knee replacement (TKR) is an effective and definitive treatment. However, TKR is an invasive procedure with potential risk for serious complications, and it has imposed high costs on the US healthcare system, with expenses accounting for hospital expenditures of TKR estimated at $28.5 billion in 2009.¹Alternative low-risk therapies that can delay or obviate TKR are valuable to a number of patients, especially the poor candidates for surgery or those who wish to avoid TKR.

Intra-articular (IA) hyaluronic acid (HA) injections have been available as a safe and effective treatment option to alleviate pain and to improve joint functions.² Results of randomized double-blind controlled clinical trials have demonstrated the pain-relieving effect of IA HA injections.^3-5 Furthermore, a recent network meta-analysis comparing various pharmacologic interventions for knee OA has confirmed the efficacy of IA HA injections, which outperformed other interventions when compared with oral placebos.^6,7 IA therapies are more effective than oral therapies for knee OA pain, with IA HA injections demonstrating the most pain reduction, potentially due to the benefit associated with needle injection and aspiration. Recent experimental studies have also suggested that IA HA may provide cartilage protection, reduce inflammation, and boost the viscosity of synovial fluid;⁸ IA HA may also exert therapeutic effects by inhibiting bone formation in OA patients.^9,10 HA possesses the potential to delay or obviate TKR. Previous research with a case series review of patients in an orthopedic specialty practice reported that the use of IA HA injections in patients with grade IV OA delayed TKR substantially.¹¹ One study analyzed retrospective medical claims data from a single private insurer and discovered potential evidence for the modest benefit of IA HA injections in delaying TKR.¹²

More detailed research work on a large sample of patients with knee OA and the requirement of TKR as a condition for inclusion using US administrative claims data has demonstrated the TKR-delaying effects of IA HA injections in comparison with a control group without claims for IA HA injections.^13,14 This study also uses real-world US administrative data but utilizes a different approach by starting with a sample of patients with knee OA and evidence of IA HA injections and then assessing the effect of repeated courses of HA treatment on the delay of TKR, without TKR as a mandatory condition for inclusion. All patients with knee OA within the time window were included, regardless of the need for TKR compared with previous studies which only considered patients who ultimately received TKR. Safety information and effectiveness information were examined to achieve a balanced risk-benefit assessment. We also analyzed how multiple courses of HA treatment and other potentially relevant covariates at baseline affected the risk of receiving TKR in a multivariate survival model. We aimed to achieve a realistic assessment of the clinical utility of HA injections in delaying TKR in a real-world setting using both safety and effectiveness data.

METHODS

DATA SOURCE

A retrospective cohort observational study using IMS Health’s PharMetrics Plus Health Plan Claims Database was conducted by identifying knee OA patients with claims indicating initiation of HA injection at an index date during the selection period (July 1, 2007 to June 30, 2010). All common HA agents in the US market during this period (Euflexxa, Hyalgan, Orthovisc, Supartz, and Synvisc) were selected via the corresponding J-codes and pooled for investigation of HA class effects. The follow-up period was 36 months, post-index date of the initial HA injection. Outcomes were measured, and adverse events were identified during this period. The time window for identification of adverse events was within 2 weeks from any injection during the course of therapy (evidence of an emergency room visit and/or physician office visit with requisite code). The data during the 12-month pre-index baseline period from the claims database was used to obtain information about baseline patient characteristics, such as age, gender, type of coverage, physician specialty, Charlson Comorbidity Index (CCI), major comorbidities, and major medications of interest commonly used among patients with knee OA.

STUDY SAMPLE SELECTION

The eligible patients required an outpatient claim indicating the initiation of HA injection. The date of the first claim for the patient within the selection window was defined as their index date. Patients had to be ≥18 years of age in the year of their index date. They had to present at least 1 clinical knee OA diagnosis at any point in the 12-month pre-index period (including the index date), and only patients who were continuously enrolled from 12 months pre-index to 36 months post-index date were evaluated. Among these patients (approximately 1.4 million), the following were excluded to minimize complications in data analysis and interpretation: patients with evidence of any HA use in the pre-index period; patients with evidence of a different kind of HA index medication in the post-index period; patients with evidence of TKR within 30 days of the index event during the post-index period; patients with evidence of 2 different kinds of HA index medications on the index date; and patients with evidence of diagnosis of hip OA, fibromyalgia, rheumatoid arthritis, lupus, or gout during the pre-index period.

Five patient cohorts were defined according to the number of courses of IA HA injections over the entire post-index period.

Continue to: Statistical analysis...

STATISTICAL ANALYSIS

All statistical analyses were performed using SAS version 9.2 (SAS Institute Inc.). Descriptive statistics such as means, standard deviations, medians, and 25% and 75% percentiles (Q1 and Q3, respectively) were provided for the continuous variables. Numbers and percentages were provided for the categorical variables. For statistical testing, Student’s t-tests were applied for the continuous variables and chi-square tests for the categorical variables. All the statistical tests were two-tailed. The sample sizes in this database study are remarkably large, such that differences that are not clinically important could still be statistically significant at the conventional alpha level of 0.05. Thus, we applied a more stringent requirement of the alpha level of 0.0001 to identify highly statistically significant results. The number and percentage of patients within each cohort with at least 1 instance of an adverse event of interest (those adverse events commonly expected for patients who receive IA injections for knee OA) were assessed. Times to TKR during the 36-month post-index period were analyzed and compared among different cohorts. Any patients who had not undergone TKR by the end of the post-index period were considered censored at 36 months. The Kaplan-Meier method was employed to model survival curves with time to TKR data, and log-rank tests were used to compare survival curves among different cohorts. A Cox proportional hazards model (PHM) was used to model the risk of TKR with a pre-specified set of covariates adjusted for baseline attributes, such as age, gender, comorbidities, and pre-index healthcare costs. Hazard ratios with 95% confidence intervals were used to examine the measures of event risk.

RESULTS

PATIENT CHARACTERISTICS

Applying study selection criteria to the claims database yielded 50,389 patients (Figure 1), providing an ample sample size for the statistical analysis. Only patients with evidence of knee OA and use of HA injections (the index medication of interest) were selected, regardless of whether they received TKR during the post-index period. The requirement for a knee OA diagnosis during the 12-month pre-index period resulted in the significant attrition of patients, with 584,956 patients being excluded. Among the 50,389 patients who received HA for treatment of knee OA, 36,260 (72.0%) received a single course of treatment, 8709 (17.3%) received 2 courses, 3179 (6.3%) received 3 courses, 1354 (2.7%) received 4 courses, and 887 (1.8%) received ≥5 courses of treatment.

Comparison of baseline characteristics among the 5 IA HA cohorts showed the fairly similar baseline characteristics of all cohorts (Table 1). Geographic region, physician specialty, and opioid use showed differences among the cohorts. Cohorts with ≥5 HA courses presented lower proportions of patients from Southern US states, patients seeing orthopedic surgeons, and patients using opioids than cohorts with fewer HA courses.

PROCEDURES OF INTEREST

An analysis of the procedures patients received after HA treatment initiation showed that higher numbers of HA treatment courses resulted in lower proportions of patients receiving TKR within 3 years after HA treatment initiation (Table 2). With an increasing number of HA treatment courses, the proportion of patients with TKR within 3 years post-index consistently decreased from 28.4% (for 1 HA course) to 5.0% (for ≥5 HA courses), with all differences being highly statistically significant (P < .0001). Similarly, partial knee replacement exhibited a similar trend, with the proportion of patients decreasing from 3.3% (for 1 HA course) to 0.8% (for ≥5 HA courses; P < .0001). Among the patients with TKR within 3 years post-index, increasing numbers of treatment courses correlated with increasing time to TKR, with a mean of 375.6 days (for 1 HA course) rising to a mean of 971.5 days (for ≥5 HA courses; P < .0001). On the other hand, patients with multiple courses of HA treatment were more likely to undergo radiologic examinations of the knee, arthrocenteses, and image-guided injections than patients with only a single course of HA treatment (P < .0001).

ADVERSE EVENTS

Arthralgia and joint pain in the knee were the most commonly recorded adverse events (Table 3). More courses of HA treatment were associated with higher rates of adverse events. Overall, the reported adverse events profile of repeated courses of HA treatment consisted of mostly common and mild adverse events and displayed no safety concern for patients with knee OA that was followed-up for 3 years. The causality of these adverse events directly related to HA injections vs a specific disease state cannot be determined from an administrative claims data set.

TIME TO TKR

Successive courses of HA led to high proportions of patients without TKR 3 years after HA treatment initiation. This result is evident in the Kaplan-Meier survival curves of time to TKR for different HA cohorts (Figure 2), with log-rank tests of multiple courses vs a single course of HA (P < .0001) showing highly statistically significance. Tabulation of proportions of patients without TKR by various time points showed that increasing numbers of HA treatment courses correlated with higher proportions of patients without TKR at almost all time points (Table 4); within 3 years post-index, 71.6% of patients in the 1 HA course cohort exhibited no TKR, whereas 95.0% of patients in ≥5 HA courses cohort presented no TKR. We also performed a multivariate Cox PHM (Table 5) to account for baseline characteristics of different HA cohorts with covariates when estimating the risks of receiving TKR. The results of the Cox PHM showed that multiple courses of HA treatment significantly decreased the risk of TKR (hazard ratio, 0.138 for ≥5 HA courses vs 1 HA course; P < .0001). Inspection of other highly significant covariates showed that being older, living in the Midwest region of the US (vs the Northeast), receiving pre-index corticosteroids, having an orthopedic surgeon as a treating physician (vs a general practitioner, a rheumatologist, or a physical medicine and rehabilitation specialist), experiencing hypertension or hyperlipidemia, and higher pre-index total healthcare costs were associated with an increased risk of TKR (all P < .0001). Vascular disease and high CCI scores were associated with a decreased risk of TKR (P < .0001).

Continue to: Discussion...

DISCUSSION

This study demonstrated that multiple courses of HA treatment can delay the need for surgery for up to 3 years, with risk for both TKR and partial knee replacement decreasing in a dose-dependent manner. The potentially confounding effect of differences in baseline characteristics that could influence patients’ propensity to receive TKR in a database study was controlled by performing a multivariate analysis with covariate adjustment. The TKR-delaying effect of HA injection was more prominent in cohorts with a high number of HA treatment courses: 19 out of 20 patients in the cohort of ≥5 HA courses were free of TKR at the end of the 3-year post-index period. Such a high proportion of patients avoiding TKR with repeated courses of HA suggests that some patients may be able to successfully delay TKR well beyond the 3-year time span. This finding is counter-evidence to the frequently made assumption¹⁵ that all patients with knee OA will eventually progress to a state of disability, making TKR inevitable. The patients with end-stage radiographic knee OA can also benefit from IA HA injections for an extended period of time;¹⁶ the latest evidence indicates that nonoperative management can improve symptoms irrespective of radiographic disease severity, implying that TKR needs not to be the only therapeutic option for patients with end-stage radiographic knee OA.¹⁷ This finding suggests that HA treatment should be considered an important clinical treatment option for patients with knee OA.

Although the incidence rates of certain adverse events, such as arthralgia/joint pain, are sizable, these temporary adverse events commonly occur among patients who receive IA injections for knee OA; most of these events may simply include symptoms of the remaining underlying knee OA. These results are consistent with those of previous literature reporting the safety of repeated treatment with IA HA injections in a prospective clinical trial¹⁸ and demonstrating that repeated courses of HA treatment pose no greater safety risk than a single course of HA treatment.

Multivariate modeling outcomes of factors influencing risk of receiving TKR are broadly consistent with the generally accepted notions that different levels of disease severity and patients’ willingness to consider TKR at baseline influence the likelihood and timing of receiving TKR.^19,20 Age and obesity are common risk factors for progression of OA. Orthopedic surgeons are more likely to recommend surgery than non-surgeons. The pre-index use of corticosteroids and high pre-index healthcare costs could be associated with more severe symptoms at baseline. Patients with vascular disease or severe comorbidities, as evidenced by high CCI scores, make poor candidates for major elective surgeries such as TKR. These results are intuitive and validate the clinical insights of this study. Moreover, inclusion of these covariates in the analysis model allows for indirect adjustment of the most important prognostic factors for TKR at baseline, permitting proper statistical comparison of the results for different cohort groups.

Recently, the efficacy of HA injections for OA patients has become the subject of debate when the American Academy of Orthopaedic Surgeons (AAOS) revised its clinical practice guideline, recommending against the use of HA.²¹ The AAOS’ findings differ from those of other clinical societies, such as the American College of Rheumatology²² and the European League Against Rheumatism,²³ which provide no strong recommendation against the use of HA injections. The announcement of the new guideline by AAOS caused concern among clinicians and payers who had valued IA HA injections as a means to control knee OA pain before patients progress to TKR;²⁴ on the other hand, the demand for nonoperative treatment of knee OA remains high. Utilization rates of TKR have increased dramatically, and surgeries are now performed on younger patients with increasing burden on the healthcare system,^25,26 in spite of the fact that as high as a third of TKR surgeries may have been performed in inappropriate patients.²⁷ Part of the confusion surrounding clinical utility of HA stems from the fact that up until recently, relatively little research looked into the practical benefits of HA in actual clinical practice. Analyses of databases such as registries are now gaining attention to overcome that problem. Examination of large administrative databases maintained by commercial payers offers the benefit of probing realistically the safety and efficacy of treatments in actual clinical environments in a very large number of patients with heterogeneous backgrounds. Recently, the Agency for Healthcare Research and Quality’s Technology Assessment Program in the US called for such studies to determine whether HA injections can delay progression to TKR.²⁸ The results of this study and several others^11,13,14,16 suggest that use of HA to treat OA of the knee is associated with the delay of TKR, supporting the utility of HA in clinical practice and the healthcare system. Potential clinical benefits of delaying TKR may include the reduced risk of aseptic loosening if younger patients can wait for TKR or more time to allow the modification of risk factors in patients who will ultimately undergo TKR.

LIMITATIONS

Follow-up period was limited to 3 years post-index date because longer follow-up data were not available at the time of the study design. If an incorrect adverse event or OA diagnosis was listed in the medical record, or if the medical record was incomplete, then patients might have been misclassified, resulting in selection bias. The claims dataset includes no uninsured and Medicare patients, as the population in the database consisted primarily of commercially-insured patients in the US. Therefore, the results are most generalizable to other commercially-insured patients in the US. Generalizability to other populations may not be assured if they differ in their accessibility to physician services or prescriptions from the patients in this study. Other treatments such as the nonsteroidal anti-inflammatory drugs used by patients were not included within the pre-specified statistical model because their potential effects were assumed to be short-lived and much less than those of corticosteroid. Including these treatments would overload the statistical model with too many covariates, leading to potential computational instability. The database used provides no information on systemic factors, including plan limits on medication use, that could affect care. Given the large and diverse nature of the healthcare plans in the database. However, these factors should not have materially affected our study results. The claims database also lacks direct indicators of OA disease severity, such as Kellgren-Lawrence scores or patient-reported outcomes, including pain and function questionnaire scores. Our multivariate analysis indirectly makes up for this deficiency by considering other baseline characteristics or clinical indicators that may be correlated with information unavailable in a claims database. Patients who opt to undergo repeated courses of HA treatment may be more inclined to avoid surgery or may naturally experience OA disease progression more slowly, making them potentially different from patients who select to undergo surgery earlier without repeated courses of HA treatment. This condition may introduce a bias that causes difficulty in proving the causality between repeated HA use and delay of TKR.

CONCLUSION

Analysis of the knee OA patient data from a real-world database showed that repeated courses of treatment with HA are safe and are associated with the delay of TKR for up to 3 years. Additional research is needed to evaluate the effects of repeated HA courses on delaying TKR beyond a 3-year period.

ABSTRACT

Vascular injury to the popliteal artery during knee surgery is uncommon, but it has significant consequences not only for the patient but also to the surgeon since it poses the threat of malpractice litigation. The vascular anatomy of the lower extremity is variable especially when it involves both the popliteal artery and its branches. An aberrant vascular course may increase the risk of iatrogenic vascular injury during surgery. Careful preoperative planning with advanced imaging can decrease the risk of a devastating vascular injury.

Continue to: Most non-traumatic injuries...

Most non-traumatic injuries to the popliteal artery are iatrogenic and may occur during total knee replacement,^1-8 high tibial osteotomy,^2,3,5-7 anterior cruciate ligament reconstruction,^2,6 posterior cruciate ligament reconstruction,^2,6,9,10 and arthroscopic meniscectomy.^2,6,9 Despite the rare occurrence of complications involving the popliteal artery during such procedures, results of vessel injuries can be devastating and may also lead to malpractice litigation. Anatomic variations of the distal popliteal artery and its significance in surgery have been well documented in the literature.^2-6,8,11 However, due to lack of awareness, this issue is often unintentionally disregarded. We present the case of an aberrant anterior tibial artery that was found during the review of a magnetic resonance imaging study. The patient was provided written informed consent for print and electronic publication of this case report.

CASE

A 61-year-old woman presented with a history of right knee pain from osteoarthritis that had rapidly progressed over 1 week secondary to a fall. The patient had no history of previous knee surgery. After careful evaluation of her right knee pain, treatment options were discussed. The patient agreed to proceed with total knee arthroplasty (TKA). During preoperative planning, the patient’s previous magnetic resonance imaging (MRI) was reviewed. The MRI study revealed an aberrant anterior tibial artery. The popliteal artery bifurcated at the level of the knee joint (Figures 1A-1C). After the bifurcation, the anterior tibial artery coursed anteriorly to the tibioperoneal trunk. The anterior tibial artery is seen just anterior to the popliteus muscle and just posterior to the tibial plateau cortex (Figure 2). Intraoperatively, an oscillating saw was utilized for the tibial cut. Care was taken not to penetrate the posterior cortex. An osteotome was used to elevate the tibial cut and hinge it open, and with a small mallet, finish the tibial cut. The patient had a successful TKA without complication.

DISCUSSION

Emerging from the adductor hiatus (Hunter’s canal), the normal course of the popliteal artery is a position slightly lateral in the intercondylar fossa. It courses obliquely and posteriorly to the popliteus then bifurcates into the anterior tibial artery and the tibioperoneal trunk at the inferior border of the popliteus. The tibioperoneal trunk bifurcates into both the posterior tibial artery and the peroneal artery at the proximal tibia well below the knee joint.

There are many reported cases of popliteal artery variations.^{2,3,6,7,9,11-13} Variations in the popliteal artery are consequences of persistent embryonic vessels from primitive segments of the artery or abnormal fusions among them.¹⁴ According to Kim and colleagues,¹¹ variations can be classified by the modified Lippert’s system. This system has 3 categories with 3 subtypes (Table). Variations are not uncommon and occur in 7.4% to 12% of the population.^2,4,5,7,13

Table. Modified Lippert’s System¹¹

Of these variations, type IIA, a high bifurcation of the anterior tibial artery, arising at or above the knee joint from the popliteal artery is the most significant. Forty-two percent of these vessels course anterior to the popliteus and make direct contact with the cortex of the posterior tibia.⁴ It is also the most frequent variant type reported in 1.2% to 6% of the population.^3,7,11-13

Continue to: Injury to the popliteal artery...

Injury to the popliteal artery during an orthopedic procedure is believed to be under reported⁶ but is considered a rare complication. The incidence of popliteal artery injury in TKA is thought to be 0.03% to 0.2%.^1,2,5,7,8 Vessel injury in both high tibial osteotomy and arthroscopic surgeries (lateral meniscal repair) have also been reported.^5,6,8,10 Despite the rare occurrence of this complication, it may have devastating outcomes. The injury can be repaired with vascular grafting depending on its severity; however, it could also lead to compartment syndrome, loss of function, chronic ulcers, and necrosis of the affected limb resulting in below the knee amputation. The current consensus is that the popliteal artery moves posteriorly away from the tibia when the knee is in 90^° of flexion,⁵ which is the standard position for many orthopedic knee surgeries. This position limits the risk of injuring the vessel. However, Metzdorf and colleagues,⁴ Smith and colleagues,⁶ and Zaidi and colleagues⁸ suggested that the vessel not be displaced posteriorly with flexion. These studies reported that the behavior of the popliteal artery varied among individuals since in some cases it had moved closer to the tibia in flexion when compared with extension.

Regardless of the behavior of the artery, it is protected by the popliteus muscle in most orthopedic knee surgeries since the majority course posterior to the muscle. However, in cases of Lippert’s type IIA variation, it not only loses protection as it courses beneath the popliteus but also is extremely vulnerable from the close relationship to the posterior tibial cortex. Klecker and colleagues² described the aberrant artery locations related to common orthopedic procedures, which demonstrated its close proximity to various surgical plane levels. The position of the aberrant artery is approximately 1 to 1.5 cm distal to the posterior tibial joint line, just posterior to the posterior capsule, and close to the posterior cruciate ligament insertion site where the transverse tibial cut is made during TKA. This location also corresponds to the position for an inlay block and the tibial tunnel for posterior cruciate ligament reconstruction. A transverse cut for a high tibial osteotomy is approximately 1.5 to 2.5 cm distal to the posterior tibial joint line; the aberrant artery appeared directly posterior to the tibial cortex. These relationships were equivalent findings in this case. Such relationships of the aberrant anterior tibial artery to both the posterior tibial cortex and the posterior capsule increase the risk of vessel (anterior tibial artery) injury intraoperatively. The risk further increases in a revision of total knee replacement. This is secondary to limited flexibility of the vessel from scar formation which requires a more distal incision.^1,4

CONCLUSION

Vascular injuries in knee surgeries are rare and often overlooked. Despite their low occurrence rate, outcomes of these injuries have grave consequences not only regarding medical but also legal matters. Variations in the popliteal artery are not uncommon and could potentially contribute to risks of vessel injury. Of these variations, the high originating anterior tibial artery poses a special risk. However, due to the low occurrence rate of these injuries, screening the general population may not be cost-effective. Since many patients already have obtained necessary imaging (preferably MRI), a careful review of these images along with preoperative planning and special care during surgery is recommended to identify popliteal artery variants and avoid iatrogenic vascular injury.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Vascular injury to the popliteal artery during knee surgery is uncommon, but it has significant consequences not only for the patient but also to the surgeon since it poses the threat of malpractice litigation. The vascular anatomy of the lower extremity is variable especially when it involves both the popliteal artery and its branches. An aberrant vascular course may increase the risk of iatrogenic vascular injury during surgery. Careful preoperative planning with advanced imaging can decrease the risk of a devastating vascular injury.

Continue to: Most non-traumatic injuries...

Most non-traumatic injuries to the popliteal artery are iatrogenic and may occur during total knee replacement,^1-8 high tibial osteotomy,^2,3,5-7 anterior cruciate ligament reconstruction,^2,6 posterior cruciate ligament reconstruction,^2,6,9,10 and arthroscopic meniscectomy.^2,6,9 Despite the rare occurrence of complications involving the popliteal artery during such procedures, results of vessel injuries can be devastating and may also lead to malpractice litigation. Anatomic variations of the distal popliteal artery and its significance in surgery have been well documented in the literature.^2-6,8,11 However, due to lack of awareness, this issue is often unintentionally disregarded. We present the case of an aberrant anterior tibial artery that was found during the review of a magnetic resonance imaging study. The patient was provided written informed consent for print and electronic publication of this case report.

CASE

A 61-year-old woman presented with a history of right knee pain from osteoarthritis that had rapidly progressed over 1 week secondary to a fall. The patient had no history of previous knee surgery. After careful evaluation of her right knee pain, treatment options were discussed. The patient agreed to proceed with total knee arthroplasty (TKA). During preoperative planning, the patient’s previous magnetic resonance imaging (MRI) was reviewed. The MRI study revealed an aberrant anterior tibial artery. The popliteal artery bifurcated at the level of the knee joint (Figures 1A-1C). After the bifurcation, the anterior tibial artery coursed anteriorly to the tibioperoneal trunk. The anterior tibial artery is seen just anterior to the popliteus muscle and just posterior to the tibial plateau cortex (Figure 2). Intraoperatively, an oscillating saw was utilized for the tibial cut. Care was taken not to penetrate the posterior cortex. An osteotome was used to elevate the tibial cut and hinge it open, and with a small mallet, finish the tibial cut. The patient had a successful TKA without complication.

DISCUSSION

Emerging from the adductor hiatus (Hunter’s canal), the normal course of the popliteal artery is a position slightly lateral in the intercondylar fossa. It courses obliquely and posteriorly to the popliteus then bifurcates into the anterior tibial artery and the tibioperoneal trunk at the inferior border of the popliteus. The tibioperoneal trunk bifurcates into both the posterior tibial artery and the peroneal artery at the proximal tibia well below the knee joint.

There are many reported cases of popliteal artery variations.^{2,3,6,7,9,11-13} Variations in the popliteal artery are consequences of persistent embryonic vessels from primitive segments of the artery or abnormal fusions among them.¹⁴ According to Kim and colleagues,¹¹ variations can be classified by the modified Lippert’s system. This system has 3 categories with 3 subtypes (Table). Variations are not uncommon and occur in 7.4% to 12% of the population.^2,4,5,7,13

Table. Modified Lippert’s System¹¹

Of these variations, type IIA, a high bifurcation of the anterior tibial artery, arising at or above the knee joint from the popliteal artery is the most significant. Forty-two percent of these vessels course anterior to the popliteus and make direct contact with the cortex of the posterior tibia.⁴ It is also the most frequent variant type reported in 1.2% to 6% of the population.^3,7,11-13

Continue to: Injury to the popliteal artery...

Injury to the popliteal artery during an orthopedic procedure is believed to be under reported⁶ but is considered a rare complication. The incidence of popliteal artery injury in TKA is thought to be 0.03% to 0.2%.^1,2,5,7,8 Vessel injury in both high tibial osteotomy and arthroscopic surgeries (lateral meniscal repair) have also been reported.^5,6,8,10 Despite the rare occurrence of this complication, it may have devastating outcomes. The injury can be repaired with vascular grafting depending on its severity; however, it could also lead to compartment syndrome, loss of function, chronic ulcers, and necrosis of the affected limb resulting in below the knee amputation. The current consensus is that the popliteal artery moves posteriorly away from the tibia when the knee is in 90^° of flexion,⁵ which is the standard position for many orthopedic knee surgeries. This position limits the risk of injuring the vessel. However, Metzdorf and colleagues,⁴ Smith and colleagues,⁶ and Zaidi and colleagues⁸ suggested that the vessel not be displaced posteriorly with flexion. These studies reported that the behavior of the popliteal artery varied among individuals since in some cases it had moved closer to the tibia in flexion when compared with extension.

Regardless of the behavior of the artery, it is protected by the popliteus muscle in most orthopedic knee surgeries since the majority course posterior to the muscle. However, in cases of Lippert’s type IIA variation, it not only loses protection as it courses beneath the popliteus but also is extremely vulnerable from the close relationship to the posterior tibial cortex. Klecker and colleagues² described the aberrant artery locations related to common orthopedic procedures, which demonstrated its close proximity to various surgical plane levels. The position of the aberrant artery is approximately 1 to 1.5 cm distal to the posterior tibial joint line, just posterior to the posterior capsule, and close to the posterior cruciate ligament insertion site where the transverse tibial cut is made during TKA. This location also corresponds to the position for an inlay block and the tibial tunnel for posterior cruciate ligament reconstruction. A transverse cut for a high tibial osteotomy is approximately 1.5 to 2.5 cm distal to the posterior tibial joint line; the aberrant artery appeared directly posterior to the tibial cortex. These relationships were equivalent findings in this case. Such relationships of the aberrant anterior tibial artery to both the posterior tibial cortex and the posterior capsule increase the risk of vessel (anterior tibial artery) injury intraoperatively. The risk further increases in a revision of total knee replacement. This is secondary to limited flexibility of the vessel from scar formation which requires a more distal incision.^1,4

CONCLUSION

Vascular injuries in knee surgeries are rare and often overlooked. Despite their low occurrence rate, outcomes of these injuries have grave consequences not only regarding medical but also legal matters. Variations in the popliteal artery are not uncommon and could potentially contribute to risks of vessel injury. Of these variations, the high originating anterior tibial artery poses a special risk. However, due to the low occurrence rate of these injuries, screening the general population may not be cost-effective. Since many patients already have obtained necessary imaging (preferably MRI), a careful review of these images along with preoperative planning and special care during surgery is recommended to identify popliteal artery variants and avoid iatrogenic vascular injury.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

Vascular injury to the popliteal artery during knee surgery is uncommon, but it has significant consequences not only for the patient but also to the surgeon since it poses the threat of malpractice litigation. The vascular anatomy of the lower extremity is variable especially when it involves both the popliteal artery and its branches. An aberrant vascular course may increase the risk of iatrogenic vascular injury during surgery. Careful preoperative planning with advanced imaging can decrease the risk of a devastating vascular injury.

Continue to: Most non-traumatic injuries...

Most non-traumatic injuries to the popliteal artery are iatrogenic and may occur during total knee replacement,^1-8 high tibial osteotomy,^2,3,5-7 anterior cruciate ligament reconstruction,^2,6 posterior cruciate ligament reconstruction,^2,6,9,10 and arthroscopic meniscectomy.^2,6,9 Despite the rare occurrence of complications involving the popliteal artery during such procedures, results of vessel injuries can be devastating and may also lead to malpractice litigation. Anatomic variations of the distal popliteal artery and its significance in surgery have been well documented in the literature.^2-6,8,11 However, due to lack of awareness, this issue is often unintentionally disregarded. We present the case of an aberrant anterior tibial artery that was found during the review of a magnetic resonance imaging study. The patient was provided written informed consent for print and electronic publication of this case report.

CASE

A 61-year-old woman presented with a history of right knee pain from osteoarthritis that had rapidly progressed over 1 week secondary to a fall. The patient had no history of previous knee surgery. After careful evaluation of her right knee pain, treatment options were discussed. The patient agreed to proceed with total knee arthroplasty (TKA). During preoperative planning, the patient’s previous magnetic resonance imaging (MRI) was reviewed. The MRI study revealed an aberrant anterior tibial artery. The popliteal artery bifurcated at the level of the knee joint (Figures 1A-1C). After the bifurcation, the anterior tibial artery coursed anteriorly to the tibioperoneal trunk. The anterior tibial artery is seen just anterior to the popliteus muscle and just posterior to the tibial plateau cortex (Figure 2). Intraoperatively, an oscillating saw was utilized for the tibial cut. Care was taken not to penetrate the posterior cortex. An osteotome was used to elevate the tibial cut and hinge it open, and with a small mallet, finish the tibial cut. The patient had a successful TKA without complication.

DISCUSSION

Emerging from the adductor hiatus (Hunter’s canal), the normal course of the popliteal artery is a position slightly lateral in the intercondylar fossa. It courses obliquely and posteriorly to the popliteus then bifurcates into the anterior tibial artery and the tibioperoneal trunk at the inferior border of the popliteus. The tibioperoneal trunk bifurcates into both the posterior tibial artery and the peroneal artery at the proximal tibia well below the knee joint.

There are many reported cases of popliteal artery variations.^{2,3,6,7,9,11-13} Variations in the popliteal artery are consequences of persistent embryonic vessels from primitive segments of the artery or abnormal fusions among them.¹⁴ According to Kim and colleagues,¹¹ variations can be classified by the modified Lippert’s system. This system has 3 categories with 3 subtypes (Table). Variations are not uncommon and occur in 7.4% to 12% of the population.^2,4,5,7,13

Table. Modified Lippert’s System¹¹

Of these variations, type IIA, a high bifurcation of the anterior tibial artery, arising at or above the knee joint from the popliteal artery is the most significant. Forty-two percent of these vessels course anterior to the popliteus and make direct contact with the cortex of the posterior tibia.⁴ It is also the most frequent variant type reported in 1.2% to 6% of the population.^3,7,11-13

Continue to: Injury to the popliteal artery...

Injury to the popliteal artery during an orthopedic procedure is believed to be under reported⁶ but is considered a rare complication. The incidence of popliteal artery injury in TKA is thought to be 0.03% to 0.2%.^1,2,5,7,8 Vessel injury in both high tibial osteotomy and arthroscopic surgeries (lateral meniscal repair) have also been reported.^5,6,8,10 Despite the rare occurrence of this complication, it may have devastating outcomes. The injury can be repaired with vascular grafting depending on its severity; however, it could also lead to compartment syndrome, loss of function, chronic ulcers, and necrosis of the affected limb resulting in below the knee amputation. The current consensus is that the popliteal artery moves posteriorly away from the tibia when the knee is in 90^° of flexion,⁵ which is the standard position for many orthopedic knee surgeries. This position limits the risk of injuring the vessel. However, Metzdorf and colleagues,⁴ Smith and colleagues,⁶ and Zaidi and colleagues⁸ suggested that the vessel not be displaced posteriorly with flexion. These studies reported that the behavior of the popliteal artery varied among individuals since in some cases it had moved closer to the tibia in flexion when compared with extension.

Regardless of the behavior of the artery, it is protected by the popliteus muscle in most orthopedic knee surgeries since the majority course posterior to the muscle. However, in cases of Lippert’s type IIA variation, it not only loses protection as it courses beneath the popliteus but also is extremely vulnerable from the close relationship to the posterior tibial cortex. Klecker and colleagues² described the aberrant artery locations related to common orthopedic procedures, which demonstrated its close proximity to various surgical plane levels. The position of the aberrant artery is approximately 1 to 1.5 cm distal to the posterior tibial joint line, just posterior to the posterior capsule, and close to the posterior cruciate ligament insertion site where the transverse tibial cut is made during TKA. This location also corresponds to the position for an inlay block and the tibial tunnel for posterior cruciate ligament reconstruction. A transverse cut for a high tibial osteotomy is approximately 1.5 to 2.5 cm distal to the posterior tibial joint line; the aberrant artery appeared directly posterior to the tibial cortex. These relationships were equivalent findings in this case. Such relationships of the aberrant anterior tibial artery to both the posterior tibial cortex and the posterior capsule increase the risk of vessel (anterior tibial artery) injury intraoperatively. The risk further increases in a revision of total knee replacement. This is secondary to limited flexibility of the vessel from scar formation which requires a more distal incision.^1,4

CONCLUSION

Vascular injuries in knee surgeries are rare and often overlooked. Despite their low occurrence rate, outcomes of these injuries have grave consequences not only regarding medical but also legal matters. Variations in the popliteal artery are not uncommon and could potentially contribute to risks of vessel injury. Of these variations, the high originating anterior tibial artery poses a special risk. However, due to the low occurrence rate of these injuries, screening the general population may not be cost-effective. Since many patients already have obtained necessary imaging (preferably MRI), a careful review of these images along with preoperative planning and special care during surgery is recommended to identify popliteal artery variants and avoid iatrogenic vascular injury.

This paper will be judged for the Resident Writer’s Award.

ABSTRACT

A 23-year-old male active duty soldier presented with a biceps femoris tendon snapping over the fibular head with flexion of the knee beyond 90^°. Surgical release of anomalous anterolateral tibial and lateral fibular insertions provided relief of snapping with no other repair or reconstruction required. The soldier quickly returned to full running and active duty.

Snapping biceps femoris tendon is a rare but potential cause of pain and dysfunction in the lateral knee. The possible anatomical variations and the cause of snapping must be considered when determining the operative approaches to this condition.

Continue to: Snapping in the knee...

Snapping in the knee is not as common as in other joints, such as the hip or ankle. The snapping sensation can occur from several pathologies, including the following: lateral meniscal tears, iliotibial band syndrome, proximal tibiofibular instability, snapping popliteus, peroneal nerve compression/neuritis, lateral discoid meniscus, rheumatoid nodules, plicae, congenital snapping knee, exostoses, or previous trauma.^1,2 A detailed history must be provided, and physical examination and appropriate imaging must be performed to narrow down the differential diagnosis and prescribe the appropriate course of treatment for snapping.

Snapping biceps femoris syndrome is a rare cause of knee snapping. This condition has been described in various case reports.^2-13 The reasons for a snapping biceps femoris can vary, and the treating provider must be ready to accommodate and treat these causes. The symptoms typically include an audible, and usually visual, lateral snapping distal to the knee joint and over the fibular head. Imaging may reveal bony abnormalities such as fibular exostoses. Magnetic resonance imaging (MRI) can aid in determining any anomalous or abnormal insertions of the biceps femoris tendon. The snapping can be debilitating, particularly in athletes or patients with high-demand occupations, and surgical intervention is often warranted. 

We present a case of an active-duty military service member with symptomatic unilateral snapping biceps femoris and review the literature for treatment of this condition. Surgical release allowed the patient a quick and unrestricted return to full mission capabilities.

The patient provided written informed consent for print and electronic publication of this case report.

CASE REPORT

A 23-year-old active-duty soldier presented to the orthopedic clinic with several months of noticeable snapping and pain over the lateral knee with attempted running and deep squatting activities, resulting in difficulty to perform his army duties. The patient reported no history of antecedent trauma. No locking of the knee or paresthesia distally into the leg or foot was observed.

The physical examination revealed a palpable and observable snapping of the long head of the biceps tendon over the fibular head with squatting beyond 90^° in the left knee. The patient presented with full strength and no instability or joint line pain throughout the knee. Application of a posterior-to-anterior directed force over the biceps femoris proximal to the insertion allowed the patient to perform a deep squat without snapping. The radiographs demonstrated no abnormal fibular morphology (Figures 1A, 1B). Axial MRI images demonstrated an anomalous slip of the tendon inserting on the anterolateral aspect of the proximal tibia in addition to the normal insertion on the posterolateral and lateral edge of the fibular head (Figure 2) as described by Terry and LaPrade.¹⁴

Continue to: A conservative treatment with physical therapy...

A conservative treatment with physical therapy, activity modification, and a Cho-Pat knee strap (to provide a posterior-to-anterior buttress and to prevent snapping) was attempted for 4 weeks. However, the patient could not tolerate the strap, and the activity restraints prevented him from performing his job as an active-duty soldier. Given the failure of conservative treatment, operative intervention was elected.

Upon exploration of the biceps femoris insertion, the accessory anterolateral tibial insertion was readily identified (Figure 3). Notably, the expected normal lateral edge insertion was thickened and extended beyond the lateral edge, distal, and anterior on to the fibular head (Figure 4). The anterolateral tibial band was released first. However, the snapping remained evident. The thickened anterior fibular accessory band was then released back to its normal, lateral edge, and at this point, no further snapping was observed with deep flexion of the knee. Inspection of the remaining posterolateral and lateral edge insertion demonstrated a healthy, 1-cm thick tendinous insertion. The accessory slips were completely excised, and the incision was closed without any additional repair or re-insertion (Figure 5). The patient presented no complications postoperatively. He was allowed to bear weight as tolerated and was limited to stretching and gravity resistance training for 4 weeks. At 1 month, the patient was released to progress back to full activity. By 8 weeks postoperative, he remained free of snapping and resumed his regular running routine and military duties without restriction or pain.

DISCUSSION

Release of the anomalous bands with no further repair or re-insertion of the biceps femoris allowed this active-duty soldier to resume full running and duty-related activities in <2 months. In this particular patient, given his anatomy, the treatment was successful. The literature indicates that optimal results and surgical approach depend upon the pathological anatomy encountered.

Date and colleagues⁴ described a similar anatomical anomaly as with our patient, whom after the release of tibial insertion, snapping was still observed, thus requiring the release of anterior fibular insertion. They noted the necessity of suturing the accessory limbs onto the periosteum of the fibular head to achieve a stable biceps femoris.

In other cases, abnormal bony anatomy of the fibula has been shown to cause snapping. Vavalle and Capozzi⁵ described a case of snapping biceps in a marathon runner, who needed partial resection of the fibular head to eliminate snapping. The runner made a full return to the sport. Fung and colleagues² described a similar approach to a 17-year-old cyclist; however, this patient presented exostoses of the bilateral fibular heads. The exostoses were bilaterally excised, and the snapping ceased. Kristensen and colleagues¹³ described a patient with an anomalous tibial insertion. Rather than releasing the tibial insertion, a partial resection of the fibular head allowed for cessation of snapping.

Other authors advocate the detachment and anatomic re-insertion of the biceps femoris into the fibular head. Bernhardson and LaPrade⁶ reported a series of 3 patients requiring this approach with excellent results. Bansal and colleagues⁸ were the first to describe a soccer player with an isolated injury to the knee as a traumatic cause for a snapping biceps femoris. After failure of conservative treatment attempts, exploration and re-insertion through a bone tunnel allowed for return to the sport. Hernandez and colleagues¹¹ and Lokiec and colleagues¹² both described the reproduction of the normal biceps femoris anatomy through re-insertion procedures after identifying patients with abnormal anatomical insertions as causes for snapping.

CONCLUSION

We presented a case of an active military service member with a unilateral snapping biceps femoris tendon due to an anomalous distal insertion on both the proximal tibia and anterior fibular head. The release of abnormal insertions and maintenance of his normal anatomical insertion allowed for a quick and effective return to running and duty at full capacity. Although other surgical approaches have been described to include partial fibular head resection or anatomical re-insertion, we believe that the approach to this rare condition should be anatomy-based as the causes of snapping can significantly vary. We believe that if the normal posterolateral and lateral edge insertions of the biceps femoris are intact, removal of the abnormal anatomy without any repair or reconstruction can safely lead to successful surgical outcomes.        

ABSTRACT

A 23-year-old male active duty soldier presented with a biceps femoris tendon snapping over the fibular head with flexion of the knee beyond 90^°. Surgical release of anomalous anterolateral tibial and lateral fibular insertions provided relief of snapping with no other repair or reconstruction required. The soldier quickly returned to full running and active duty.

Snapping biceps femoris tendon is a rare but potential cause of pain and dysfunction in the lateral knee. The possible anatomical variations and the cause of snapping must be considered when determining the operative approaches to this condition.

Continue to: Snapping in the knee...

Snapping in the knee is not as common as in other joints, such as the hip or ankle. The snapping sensation can occur from several pathologies, including the following: lateral meniscal tears, iliotibial band syndrome, proximal tibiofibular instability, snapping popliteus, peroneal nerve compression/neuritis, lateral discoid meniscus, rheumatoid nodules, plicae, congenital snapping knee, exostoses, or previous trauma.^1,2 A detailed history must be provided, and physical examination and appropriate imaging must be performed to narrow down the differential diagnosis and prescribe the appropriate course of treatment for snapping.

Snapping biceps femoris syndrome is a rare cause of knee snapping. This condition has been described in various case reports.^2-13 The reasons for a snapping biceps femoris can vary, and the treating provider must be ready to accommodate and treat these causes. The symptoms typically include an audible, and usually visual, lateral snapping distal to the knee joint and over the fibular head. Imaging may reveal bony abnormalities such as fibular exostoses. Magnetic resonance imaging (MRI) can aid in determining any anomalous or abnormal insertions of the biceps femoris tendon. The snapping can be debilitating, particularly in athletes or patients with high-demand occupations, and surgical intervention is often warranted. 

We present a case of an active-duty military service member with symptomatic unilateral snapping biceps femoris and review the literature for treatment of this condition. Surgical release allowed the patient a quick and unrestricted return to full mission capabilities.

The patient provided written informed consent for print and electronic publication of this case report.

CASE REPORT

A 23-year-old active-duty soldier presented to the orthopedic clinic with several months of noticeable snapping and pain over the lateral knee with attempted running and deep squatting activities, resulting in difficulty to perform his army duties. The patient reported no history of antecedent trauma. No locking of the knee or paresthesia distally into the leg or foot was observed.

The physical examination revealed a palpable and observable snapping of the long head of the biceps tendon over the fibular head with squatting beyond 90^° in the left knee. The patient presented with full strength and no instability or joint line pain throughout the knee. Application of a posterior-to-anterior directed force over the biceps femoris proximal to the insertion allowed the patient to perform a deep squat without snapping. The radiographs demonstrated no abnormal fibular morphology (Figures 1A, 1B). Axial MRI images demonstrated an anomalous slip of the tendon inserting on the anterolateral aspect of the proximal tibia in addition to the normal insertion on the posterolateral and lateral edge of the fibular head (Figure 2) as described by Terry and LaPrade.¹⁴

Continue to: A conservative treatment with physical therapy...

A conservative treatment with physical therapy, activity modification, and a Cho-Pat knee strap (to provide a posterior-to-anterior buttress and to prevent snapping) was attempted for 4 weeks. However, the patient could not tolerate the strap, and the activity restraints prevented him from performing his job as an active-duty soldier. Given the failure of conservative treatment, operative intervention was elected.

Upon exploration of the biceps femoris insertion, the accessory anterolateral tibial insertion was readily identified (Figure 3). Notably, the expected normal lateral edge insertion was thickened and extended beyond the lateral edge, distal, and anterior on to the fibular head (Figure 4). The anterolateral tibial band was released first. However, the snapping remained evident. The thickened anterior fibular accessory band was then released back to its normal, lateral edge, and at this point, no further snapping was observed with deep flexion of the knee. Inspection of the remaining posterolateral and lateral edge insertion demonstrated a healthy, 1-cm thick tendinous insertion. The accessory slips were completely excised, and the incision was closed without any additional repair or re-insertion (Figure 5). The patient presented no complications postoperatively. He was allowed to bear weight as tolerated and was limited to stretching and gravity resistance training for 4 weeks. At 1 month, the patient was released to progress back to full activity. By 8 weeks postoperative, he remained free of snapping and resumed his regular running routine and military duties without restriction or pain.

DISCUSSION

Release of the anomalous bands with no further repair or re-insertion of the biceps femoris allowed this active-duty soldier to resume full running and duty-related activities in <2 months. In this particular patient, given his anatomy, the treatment was successful. The literature indicates that optimal results and surgical approach depend upon the pathological anatomy encountered.

Date and colleagues⁴ described a similar anatomical anomaly as with our patient, whom after the release of tibial insertion, snapping was still observed, thus requiring the release of anterior fibular insertion. They noted the necessity of suturing the accessory limbs onto the periosteum of the fibular head to achieve a stable biceps femoris.

In other cases, abnormal bony anatomy of the fibula has been shown to cause snapping. Vavalle and Capozzi⁵ described a case of snapping biceps in a marathon runner, who needed partial resection of the fibular head to eliminate snapping. The runner made a full return to the sport. Fung and colleagues² described a similar approach to a 17-year-old cyclist; however, this patient presented exostoses of the bilateral fibular heads. The exostoses were bilaterally excised, and the snapping ceased. Kristensen and colleagues¹³ described a patient with an anomalous tibial insertion. Rather than releasing the tibial insertion, a partial resection of the fibular head allowed for cessation of snapping.

Other authors advocate the detachment and anatomic re-insertion of the biceps femoris into the fibular head. Bernhardson and LaPrade⁶ reported a series of 3 patients requiring this approach with excellent results. Bansal and colleagues⁸ were the first to describe a soccer player with an isolated injury to the knee as a traumatic cause for a snapping biceps femoris. After failure of conservative treatment attempts, exploration and re-insertion through a bone tunnel allowed for return to the sport. Hernandez and colleagues¹¹ and Lokiec and colleagues¹² both described the reproduction of the normal biceps femoris anatomy through re-insertion procedures after identifying patients with abnormal anatomical insertions as causes for snapping.

CONCLUSION

We presented a case of an active military service member with a unilateral snapping biceps femoris tendon due to an anomalous distal insertion on both the proximal tibia and anterior fibular head. The release of abnormal insertions and maintenance of his normal anatomical insertion allowed for a quick and effective return to running and duty at full capacity. Although other surgical approaches have been described to include partial fibular head resection or anatomical re-insertion, we believe that the approach to this rare condition should be anatomy-based as the causes of snapping can significantly vary. We believe that if the normal posterolateral and lateral edge insertions of the biceps femoris are intact, removal of the abnormal anatomy without any repair or reconstruction can safely lead to successful surgical outcomes.        

ABSTRACT

A 23-year-old male active duty soldier presented with a biceps femoris tendon snapping over the fibular head with flexion of the knee beyond 90^°. Surgical release of anomalous anterolateral tibial and lateral fibular insertions provided relief of snapping with no other repair or reconstruction required. The soldier quickly returned to full running and active duty.

Snapping biceps femoris tendon is a rare but potential cause of pain and dysfunction in the lateral knee. The possible anatomical variations and the cause of snapping must be considered when determining the operative approaches to this condition.

Continue to: Snapping in the knee...

Snapping in the knee is not as common as in other joints, such as the hip or ankle. The snapping sensation can occur from several pathologies, including the following: lateral meniscal tears, iliotibial band syndrome, proximal tibiofibular instability, snapping popliteus, peroneal nerve compression/neuritis, lateral discoid meniscus, rheumatoid nodules, plicae, congenital snapping knee, exostoses, or previous trauma.^1,2 A detailed history must be provided, and physical examination and appropriate imaging must be performed to narrow down the differential diagnosis and prescribe the appropriate course of treatment for snapping.

Snapping biceps femoris syndrome is a rare cause of knee snapping. This condition has been described in various case reports.^2-13 The reasons for a snapping biceps femoris can vary, and the treating provider must be ready to accommodate and treat these causes. The symptoms typically include an audible, and usually visual, lateral snapping distal to the knee joint and over the fibular head. Imaging may reveal bony abnormalities such as fibular exostoses. Magnetic resonance imaging (MRI) can aid in determining any anomalous or abnormal insertions of the biceps femoris tendon. The snapping can be debilitating, particularly in athletes or patients with high-demand occupations, and surgical intervention is often warranted. 

We present a case of an active-duty military service member with symptomatic unilateral snapping biceps femoris and review the literature for treatment of this condition. Surgical release allowed the patient a quick and unrestricted return to full mission capabilities.

The patient provided written informed consent for print and electronic publication of this case report.

CASE REPORT

A 23-year-old active-duty soldier presented to the orthopedic clinic with several months of noticeable snapping and pain over the lateral knee with attempted running and deep squatting activities, resulting in difficulty to perform his army duties. The patient reported no history of antecedent trauma. No locking of the knee or paresthesia distally into the leg or foot was observed.

The physical examination revealed a palpable and observable snapping of the long head of the biceps tendon over the fibular head with squatting beyond 90^° in the left knee. The patient presented with full strength and no instability or joint line pain throughout the knee. Application of a posterior-to-anterior directed force over the biceps femoris proximal to the insertion allowed the patient to perform a deep squat without snapping. The radiographs demonstrated no abnormal fibular morphology (Figures 1A, 1B). Axial MRI images demonstrated an anomalous slip of the tendon inserting on the anterolateral aspect of the proximal tibia in addition to the normal insertion on the posterolateral and lateral edge of the fibular head (Figure 2) as described by Terry and LaPrade.¹⁴

Continue to: A conservative treatment with physical therapy...

A conservative treatment with physical therapy, activity modification, and a Cho-Pat knee strap (to provide a posterior-to-anterior buttress and to prevent snapping) was attempted for 4 weeks. However, the patient could not tolerate the strap, and the activity restraints prevented him from performing his job as an active-duty soldier. Given the failure of conservative treatment, operative intervention was elected.

Upon exploration of the biceps femoris insertion, the accessory anterolateral tibial insertion was readily identified (Figure 3). Notably, the expected normal lateral edge insertion was thickened and extended beyond the lateral edge, distal, and anterior on to the fibular head (Figure 4). The anterolateral tibial band was released first. However, the snapping remained evident. The thickened anterior fibular accessory band was then released back to its normal, lateral edge, and at this point, no further snapping was observed with deep flexion of the knee. Inspection of the remaining posterolateral and lateral edge insertion demonstrated a healthy, 1-cm thick tendinous insertion. The accessory slips were completely excised, and the incision was closed without any additional repair or re-insertion (Figure 5). The patient presented no complications postoperatively. He was allowed to bear weight as tolerated and was limited to stretching and gravity resistance training for 4 weeks. At 1 month, the patient was released to progress back to full activity. By 8 weeks postoperative, he remained free of snapping and resumed his regular running routine and military duties without restriction or pain.

DISCUSSION

Release of the anomalous bands with no further repair or re-insertion of the biceps femoris allowed this active-duty soldier to resume full running and duty-related activities in <2 months. In this particular patient, given his anatomy, the treatment was successful. The literature indicates that optimal results and surgical approach depend upon the pathological anatomy encountered.

Date and colleagues⁴ described a similar anatomical anomaly as with our patient, whom after the release of tibial insertion, snapping was still observed, thus requiring the release of anterior fibular insertion. They noted the necessity of suturing the accessory limbs onto the periosteum of the fibular head to achieve a stable biceps femoris.

In other cases, abnormal bony anatomy of the fibula has been shown to cause snapping. Vavalle and Capozzi⁵ described a case of snapping biceps in a marathon runner, who needed partial resection of the fibular head to eliminate snapping. The runner made a full return to the sport. Fung and colleagues² described a similar approach to a 17-year-old cyclist; however, this patient presented exostoses of the bilateral fibular heads. The exostoses were bilaterally excised, and the snapping ceased. Kristensen and colleagues¹³ described a patient with an anomalous tibial insertion. Rather than releasing the tibial insertion, a partial resection of the fibular head allowed for cessation of snapping.

Other authors advocate the detachment and anatomic re-insertion of the biceps femoris into the fibular head. Bernhardson and LaPrade⁶ reported a series of 3 patients requiring this approach with excellent results. Bansal and colleagues⁸ were the first to describe a soccer player with an isolated injury to the knee as a traumatic cause for a snapping biceps femoris. After failure of conservative treatment attempts, exploration and re-insertion through a bone tunnel allowed for return to the sport. Hernandez and colleagues¹¹ and Lokiec and colleagues¹² both described the reproduction of the normal biceps femoris anatomy through re-insertion procedures after identifying patients with abnormal anatomical insertions as causes for snapping.

CONCLUSION

We presented a case of an active military service member with a unilateral snapping biceps femoris tendon due to an anomalous distal insertion on both the proximal tibia and anterior fibular head. The release of abnormal insertions and maintenance of his normal anatomical insertion allowed for a quick and effective return to running and duty at full capacity. Although other surgical approaches have been described to include partial fibular head resection or anatomical re-insertion, we believe that the approach to this rare condition should be anatomy-based as the causes of snapping can significantly vary. We believe that if the normal posterolateral and lateral edge insertions of the biceps femoris are intact, removal of the abnormal anatomy without any repair or reconstruction can safely lead to successful surgical outcomes.