Surgery vs orthosis vs watchful waiting for hallux valgus: a randomized controlled trial.

CONTEXT Hallux valgus is a common foot deformation in adults, but evidence for effectiveness of surgical and conservative treatments for this condition is limited. OBJECTIVE To compare the effectiveness of surgical and orthotic treatment with no treatment in patients with hallux valgus. DESIGN AND SETTING Randomized controlled trial conducted in 4 general community hospitals in Finland in 1997-1998, with a follow-up period of 12 months. PARTICIPANTS Two hundred nine consecutive patients (mean age, 48 years; 93% women) with a painful bunion and a hallux valgus angle 35 degrees or less. INTERVENTIONS Patients were randomly assigned to surgery (distal chevron osteotomy; n = 71), orthosis (n = 69), or a 1-year waiting list (control group, n = 69). MAIN OUTCOME MEASURES Pain intensity during walking on a visual analog scale (0-100), patient assessment of global improvement, number of painful days, cosmetic disturbance, footwear problems, functional status, and treatment satisfaction, compared among treatment groups. RESULTS Follow-up rates at 6 and 12 months were 99% and 98%, respectively. At 6 months, pain intensity decreased more in the surgical group than in the control group (adjusted mean differences, -20 [95% confidence interval (CI), -28 to -12]) and more in orthosis than in the control groups (adjusted mean difference, -14 [95% CI, -22 to -6. At 1 year, pain intensity decreased more in the surgical than in the control groups (adjusted mean difference, -19 [95% CI, -28 to -10]) and more than in the surgical and orthosis groups (adjusted mean difference, -14 [95% CI, -22 to -5]). At 1 year, 83%, 46%, and 24% in the surgery, orthosis, and control groups, respectively, thought they had improved compared with baseline (number needed to treat), 1.7 between surgical and control groups). Number of painful days, cosmetic disturbance, and footwear problems were least and functional status and satisfaction with treatment were best in the surgical group. CONCLUSIONS Surgical osteotomy is an effective treatment for painful hallux valgus. Orthoses provide short-term symptomatic relief.