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BACKGROUND: Approximately 33% of adults have some degree of hallux valgus deformity (bunion of the great toe). Surgery for hallux valgus is one of the most commonly performed orthopedic surgeries. However, there are no previous studies comparing surgery with conservative treatment that includes orthosis or watchful waiting.
POPULATION STUDIED: This study was conducted in 4 orthopedic outpatient clinics in Finland. Patients were referred by family physicians for orthopedic evaluation of hallux valgus. The study participants were 209 adults with a mean age of 48 years. Most (93%) were women, and all had painful bunions with a hallux valgus angle of 35° or less. The study groups were similar at baseline. Four control subjects underwent surgery, but were still analyzed as being in the control group (intention-to-treat analysis).
STUDY DESIGN AND VALIDITY: The study patients were randomly assigned, using a random number table and sealed envelopes (concealed assignment), to a surgical (n=71), orthosis (n=69), or control group (n=69). The surgery group received the chevron procedure. Following the surgery, the patients used an abduction toe-hold splint for 6 weeks. Those in the orthosis group had functional foot orthoses made by the negative-cast technique. Patients in the control group were asked to simply avoid surgical or orthotic therapy during the 12-month follow-up period. All study participants were administered a questionnaire at baseline and again at 6 and 12 months after randomization. Statistical analysis was performed on an intention-to-treat basis.Overall, the study was well designed. However, a major limitation is that all patients were aware of their treatment (ie, they were not blinded). Since all of the outcomes are subjective (eg, pain, quality of life) and self-reported by the patients, there is a large risk of this awareness coloring the outcome scores negatively or positively. The researchers queried study participants after randomization about their expectations for outcomes in the 3 study arms. Patients felt that at 1 year 100% of the surgery group, 83% of the orthosis group, and 18% of the control group would have less foot pain.
OUTCOMES MEASURED: The measured outcomes were patient self-report on duration of foot pain, foot pain intensity, ability to work, cosmetic disturbance, footwear problems, health-related quality-of-life index, satisfaction with treatment, and global assessment. Costs related to foot care were also calculated.
RESULTS: At the 12-month follow-up, patients in the surgery group reported less pain and disability than those in either the orthosis group or the control group. There was no significant difference between the orthosis group and the control group at 1 year, although subjects receiving orthotics reported less pain and disability than the control group at the 6-month evaluation. Surgery was significantly more expensive. The mean amount of sick time leave from work was 53 days in the surgical group, 0 days in the orthosis-treated patients, and 12 days in the control group. Patient satisfaction with treatment and global assessments were higher for the surgery group than for patients receiving orthotics or no treatment. However, under the study protocol, patients could not be blinded to treatment.
Surgical treatment of mild-to-moderate hallux valgus results in less pain and disability than either the use of orthotics or watchful waiting. However, as outcome assessments were done by patients who were not blinded to their treatment, it is possible that a patient’s previous belief that surgery is a better treatment than orthosis or watchful waiting had a profound effect on their assessment of their own improvement. The patient expectations noted by the researchers would seem to increase that possibility. Therefore, the conclusion of these researchers (orthopedic surgeons) that surgery is the preferred treatment choice is probably overstated. Although surgery provided superior outcomes, its cost and workday losses are a significant detriment. A trial of orthotics or watchful waiting remains a viable option.
BACKGROUND: Approximately 33% of adults have some degree of hallux valgus deformity (bunion of the great toe). Surgery for hallux valgus is one of the most commonly performed orthopedic surgeries. However, there are no previous studies comparing surgery with conservative treatment that includes orthosis or watchful waiting.
POPULATION STUDIED: This study was conducted in 4 orthopedic outpatient clinics in Finland. Patients were referred by family physicians for orthopedic evaluation of hallux valgus. The study participants were 209 adults with a mean age of 48 years. Most (93%) were women, and all had painful bunions with a hallux valgus angle of 35° or less. The study groups were similar at baseline. Four control subjects underwent surgery, but were still analyzed as being in the control group (intention-to-treat analysis).
STUDY DESIGN AND VALIDITY: The study patients were randomly assigned, using a random number table and sealed envelopes (concealed assignment), to a surgical (n=71), orthosis (n=69), or control group (n=69). The surgery group received the chevron procedure. Following the surgery, the patients used an abduction toe-hold splint for 6 weeks. Those in the orthosis group had functional foot orthoses made by the negative-cast technique. Patients in the control group were asked to simply avoid surgical or orthotic therapy during the 12-month follow-up period. All study participants were administered a questionnaire at baseline and again at 6 and 12 months after randomization. Statistical analysis was performed on an intention-to-treat basis.Overall, the study was well designed. However, a major limitation is that all patients were aware of their treatment (ie, they were not blinded). Since all of the outcomes are subjective (eg, pain, quality of life) and self-reported by the patients, there is a large risk of this awareness coloring the outcome scores negatively or positively. The researchers queried study participants after randomization about their expectations for outcomes in the 3 study arms. Patients felt that at 1 year 100% of the surgery group, 83% of the orthosis group, and 18% of the control group would have less foot pain.
OUTCOMES MEASURED: The measured outcomes were patient self-report on duration of foot pain, foot pain intensity, ability to work, cosmetic disturbance, footwear problems, health-related quality-of-life index, satisfaction with treatment, and global assessment. Costs related to foot care were also calculated.
RESULTS: At the 12-month follow-up, patients in the surgery group reported less pain and disability than those in either the orthosis group or the control group. There was no significant difference between the orthosis group and the control group at 1 year, although subjects receiving orthotics reported less pain and disability than the control group at the 6-month evaluation. Surgery was significantly more expensive. The mean amount of sick time leave from work was 53 days in the surgical group, 0 days in the orthosis-treated patients, and 12 days in the control group. Patient satisfaction with treatment and global assessments were higher for the surgery group than for patients receiving orthotics or no treatment. However, under the study protocol, patients could not be blinded to treatment.
Surgical treatment of mild-to-moderate hallux valgus results in less pain and disability than either the use of orthotics or watchful waiting. However, as outcome assessments were done by patients who were not blinded to their treatment, it is possible that a patient’s previous belief that surgery is a better treatment than orthosis or watchful waiting had a profound effect on their assessment of their own improvement. The patient expectations noted by the researchers would seem to increase that possibility. Therefore, the conclusion of these researchers (orthopedic surgeons) that surgery is the preferred treatment choice is probably overstated. Although surgery provided superior outcomes, its cost and workday losses are a significant detriment. A trial of orthotics or watchful waiting remains a viable option.
BACKGROUND: Approximately 33% of adults have some degree of hallux valgus deformity (bunion of the great toe). Surgery for hallux valgus is one of the most commonly performed orthopedic surgeries. However, there are no previous studies comparing surgery with conservative treatment that includes orthosis or watchful waiting.
POPULATION STUDIED: This study was conducted in 4 orthopedic outpatient clinics in Finland. Patients were referred by family physicians for orthopedic evaluation of hallux valgus. The study participants were 209 adults with a mean age of 48 years. Most (93%) were women, and all had painful bunions with a hallux valgus angle of 35° or less. The study groups were similar at baseline. Four control subjects underwent surgery, but were still analyzed as being in the control group (intention-to-treat analysis).
STUDY DESIGN AND VALIDITY: The study patients were randomly assigned, using a random number table and sealed envelopes (concealed assignment), to a surgical (n=71), orthosis (n=69), or control group (n=69). The surgery group received the chevron procedure. Following the surgery, the patients used an abduction toe-hold splint for 6 weeks. Those in the orthosis group had functional foot orthoses made by the negative-cast technique. Patients in the control group were asked to simply avoid surgical or orthotic therapy during the 12-month follow-up period. All study participants were administered a questionnaire at baseline and again at 6 and 12 months after randomization. Statistical analysis was performed on an intention-to-treat basis.Overall, the study was well designed. However, a major limitation is that all patients were aware of their treatment (ie, they were not blinded). Since all of the outcomes are subjective (eg, pain, quality of life) and self-reported by the patients, there is a large risk of this awareness coloring the outcome scores negatively or positively. The researchers queried study participants after randomization about their expectations for outcomes in the 3 study arms. Patients felt that at 1 year 100% of the surgery group, 83% of the orthosis group, and 18% of the control group would have less foot pain.
OUTCOMES MEASURED: The measured outcomes were patient self-report on duration of foot pain, foot pain intensity, ability to work, cosmetic disturbance, footwear problems, health-related quality-of-life index, satisfaction with treatment, and global assessment. Costs related to foot care were also calculated.
RESULTS: At the 12-month follow-up, patients in the surgery group reported less pain and disability than those in either the orthosis group or the control group. There was no significant difference between the orthosis group and the control group at 1 year, although subjects receiving orthotics reported less pain and disability than the control group at the 6-month evaluation. Surgery was significantly more expensive. The mean amount of sick time leave from work was 53 days in the surgical group, 0 days in the orthosis-treated patients, and 12 days in the control group. Patient satisfaction with treatment and global assessments were higher for the surgery group than for patients receiving orthotics or no treatment. However, under the study protocol, patients could not be blinded to treatment.
Surgical treatment of mild-to-moderate hallux valgus results in less pain and disability than either the use of orthotics or watchful waiting. However, as outcome assessments were done by patients who were not blinded to their treatment, it is possible that a patient’s previous belief that surgery is a better treatment than orthosis or watchful waiting had a profound effect on their assessment of their own improvement. The patient expectations noted by the researchers would seem to increase that possibility. Therefore, the conclusion of these researchers (orthopedic surgeons) that surgery is the preferred treatment choice is probably overstated. Although surgery provided superior outcomes, its cost and workday losses are a significant detriment. A trial of orthotics or watchful waiting remains a viable option.