Brace treatment for osteoarthritis of the knee: a prospective randomized multi-centre trial
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OBJECTIVE: To evaluate the effect of a brace intended to reduce load in patients with medial or lateral compartmental osteoarthritis (OA) and concurrent varus or valgus alignment, respectively. DESIGN: This multi-centre randomized controlled trial (performed 2001-2003) studies the additive effect of a brace intended to reduce load in conservative treatment of unicompartmental OA of the knee. Setting: Orthopedic department of a university medical centre and of one general hospital. The follow-up was 12 months. Patients: 117 patients with unicompartmental OA of the knee. Intervention group (n=60) comprising conservative treatment with additional brace treatment and a control group (n=57) comprising conservative treatment alone. Primary outcome measures: Pain severity and knee function score. Secondary outcome measures: Walking distance and quality of life. Analysis: Multiple linear regression models according to the intention-to-treat-principle were used to assess outcome differences for the entire group of patients. In addition, we performed explorative subgroup analyses on primary overall outcomes stratified for alignment, degree of OA, origin of OA, and age. RESULTS: Although the primary outcome measures were improved in the intervention group in comparison with the controls at each assessment point, the differences reached only borderline significance. The reported walking distances at 3 months, 12 months and overall were significantly longer in the brace group (P=0.03, P=0.04 and P=0.02, respectively). Subgroup analysis showed a better effect in the varus group, in patients with severe OA, in patients with secondary OA and in patients younger then 60 years. In total 25 patients in the brace group and 14 in the control group changed their initial treatment, mostly (74%) because of a lack of beneficial effect. CONCLUSIONS: The results indicate that a brace intended to reduce load shows small effects in patients with unicompartmental OA. However, many patients do not adhere in the long run to this kind of conservative treatment.