Original Research

Use of a Novel Magnesium-Based Resorbable Bone Cement for Augmenting Anchor and Tendon Fixation

Publish date: February 13, 2018

References

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IN VIVO RESULT

No intraoperative or postoperative complications were noted. All repairs were found to be intact based on the gross assessment and the completed biomechanical testing without failure. No statistically significant (P > 0.3) biomechanical differences were found between the techniques (Table 2). Histologic assessments showed low-to-mild pathology scores for all sites with no statistically significant (P > 0.3) differences between the techniques (Table 2). Both control and OsteoCrete rotator cuff repairs demonstrated tendon-to-bone integration via fibrous connective tissue attachment to bone. All anchors were in place with no evidence for loosening, tunnel expansion, or cyst formation. OsteoCrete-augmented anchor repairs were associated with cement remaining within their lumens along with a thin layer of cement interposed between the anchor and the bone interface around their entire periphery. The cement-bone interface was discrete with typical inflammatory cell infiltrate without evidence for infection, membrane or cyst formation, or other untoward pathologic responses. In the OsteoCrete biceps tenodesis group, the tendons filled the tunnels with a thin layer of cement remaining interposed between the tendon and the bone interface around the entire periphery. The tendon-cement-bone interface was discrete with typical inflammatory cell infiltrates and without evidence for infection, membrane or cyst formation, or other untoward pathologic responses. Tendon-to-bone integration was not observed in the control or OsteoCrete biceps tenodesis groups at the 12-week study endpoint. Representative histologic images of the rotator cuff tendon repairs and biceps tenodesis procedures are shown in Figures 3A, 3B and Figures 4A, 4B, respectively.

Table 2. Biomechanical Testing And Histologic Scoring Of Rotator Cuff And Biceps Tendon Repairs In A Preclinical Model

Procedure	Force (N) at 1 mm	Force (N) at 2 mm	Force (N) at 3 mm	Stiffness (N/mm)	Histologic Score
Rotator Cuff - Control	14.0 + 3.3	19.3 + 5.5	25.0 + 7.0	5.4 + 2.0	4.6 + 1.1
Rotator Cuff - OsteoCrete (Bone Solutions Incorporated)	14.8 + 3.7	20.4 + 6.0	26.4 + 8.5	6.3 + 2.5	3.9 + 1.7
Biceps - Control	23.1 + 6.2	35.5 + 8.5	52.6 + 15.0	17.8 + 6.4	3.4 + 1.2
Biceps - OsteoCrete	22.4 + 7.3	36.8 + 10.1	57.8 + 16.0	21.1 + 8.5	3.4 + 0.7

There were no significant differences (P < 0.05) between groups. Histologic scoring based on a 15-point scale with higher scores indicating more pathology.

DISCUSSION

The results of this study highlight the safety and efficacy of OsteoCrete in applications for the augmentation of anchor and tendon fixation in rotator cuff repair and biceps tenodesis procedures, respectively. Anchors augmented with OsteoCrete resulted in significantly increased load-to-failure pull-out strength 15 minutes after insertion. In addition, a very strong negative correlation was found between the percentage of improved load-to-failure after OsteoCrete injection and the bone quality of the humerus, which was based on the control load-to-failure values. In the validated preclinical model used in this study, OsteoCrete-based fixation was found to be noninferior to current standard-of-care techniques and was not associated with any untoward pathologic responses of humeral bone, rotator cuff tendon, or biceps tendon based on the biomechanical and histologic analyses. These data highlight the functional efficacy and biocompatibility of OsteoCrete when used for these common indications.

More than 270,000 rotator cuff procedures have been reported to be performed in the US annually (average patient age: 61 years for women, 56 years for men).²² Rotator cuff repair procedures have been associated with a 20% failure rate, with one of the causes being related to an inability for the tendon to heal, even with strong initial fixation.²³ Rotator cuff repair techniques are being continuously optimized with the goal of improving patient outcomes. This goal is being realized, primarily with respect to re-tear rates.^24,25 However, even with advanced techniques, there are still relatively high rates of failure reported, with increasing patient age serving as one of the primary negative prognostic factors.²⁶ An older patient population is associated with decreased bone mass and strength, and postmenopausal females have decreased bone quality; these factors are associated with higher rotator cuff failure rates due to poor tendon healing, with anchor fixation failure also playing a role.^27-29 Therefore, it is critically important to develop methods for augmenting implant and tendon fixation to bone to achieve functional healing. The results of this study suggest that OsteoCrete provides a valid method for accomplishing this goal based on the observation that proximal humeral anchor fixation was improved by 50% in load-to-failure 15 minutes post-injection with an even more profound impact on the anchors placed in poor-quality bone (99% increased load-to-failure 15 minutes post-injection). It is probable that the degree of improvement in fixation strength would be even greater 1 day after fixation, since the strength of OsteoCrete continues to increase over the first 30 hours of curing.

Based on the preclinical animal model data of this study, OsteoCrete augmentation of rotator cuff anchor fixation had no untoward effects on tendon healing or function and can be considered as safe for use. Previously published data also suggest that OsteoCrete may improve osseous replacement of anchors as a result of magnesium ion release, which can drive adjacent attachment and growth of osteoblasts, leading to enhanced new bone formation.^9-16,18 As such, surgeons may consider this means of anchor augmentation in situations of questionable or poor-quality bone and/or when accelerated postoperative rehabilitation protocols are desired.

A very low early incidence failure rate (1.2%) has been reported when a distal biceps tendon rupture is repaired using cortical suspensory fixation in conjunction with an interference screw.³⁰ When an early re-rupture does occur, the most common explanation for failure tends to be a lack of patient compliance, with excessive force being placed on the repair.³¹ This study was not meant to investigate the methods to increase the strength of a biceps tendon repair using OsteoCrete but instead to replace the interference screw with OsteoCrete in a safe and noninferior manner. Primary fixation was still dependent on cortical suspensory fixation; however, OsteoCrete was used to help aid in stabilization of the tendon without the need for interference screw fixation. Although rare, osteolysis and perianchor cyst formation have been reported adjacent to nonbiodegradable anchors (PEEK), along with several types of biodegradable anchors (PLLA, hydroxyapatite plus PLLA, β-tricalcium phosphate plus PLLA, and polyglycolic acid; the latter of the 3 resulted in the lowest incidence of perianchor cyst formation) in the shoulder and elbow.^32-34 Whenever osteolysis or cyst formation occurs around an anchor, it leads to decreased bone volume and potential adjacent bone weakness, which may act as a stress riser, thus increasing the risk for fracture. This potential is probably more of a concern within the proximal radius where there is a decreased amount of bone stock around the anchor.³⁴

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