For medial knee osteoarthritis (OA), operative and nonoperative treatment options are available. Two widely applied unloading therapies are a valgus unloader brace and a high tibial osteotomy (HTO). We aimed to compare the effects of a valgus unloader knee brace with an HTO on knee pain after 1 year in patients with symptomatic medial knee OA. We recruited patients from 9 Dutch hospitals between August 2014 and February 2019 for an open-labeled multi-center randomized controlled trial (Dutch Trial Register NL4200). Patients aged 18 to 65 years with symptomatic medial compartmental knee OA were randomized to either a valgus unloader brace or an HTO. The primary outcome was the pain subscale of the Knee injury and Osteoarthritis Outcome score (KOOS) after 1 year. Patients were evaluated at 3, 6, 9, 12, and 24 months. 51 patients were included in the study, of whom 23 were randomized to the unloader brace and 28 to the HTO. The HTO, compared with the unloader brace, showed a significant and clinically relevant difference at 12 months of follow-up in KOOS pain of -28 (95% confidence interval -43 to -13). We found that, on group level, an HTO is more effective in reducing knee pain than an unloader brace after 12 months.
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