Hallux valgus deformity is the most commonly observed forefoot deformity in patients with rheumatoid arthritis. This 5-year, double-blind, randomized clinical trial compared treatment orthoses with placebo orthoses for the prevention of hallux valgus deformity in the rheumatoid arthritic foot.One hundred and two subjects with active rheumatoid arthritis and with foot pain and minimal radiographic changes of the feet participated in the study. They were recruited from five arthritis clinics in the Chicago metropolitan area that are affiliated with or are teaching clinics of area medical schools. Patients were followed for 3 years.Eighty-one subjects completed the study. In a logistic regression analysis, the treatment group was 73% less likely to develop hallux valgus deformity compared with the control group (adjusted odds ratio 0.27, 95% confidence interval 0.078, 0.916 p = .04). These findings suggest that foot orthoses can prevent or slow the progression of hallux valgus deformity.