| Description: |
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.Objective To determine whether adding compartment specific knee bracing with an adherence intervention to advice, written information, and exercise instruction (AIE+B) is superior to advice, written information, and exercise instruction (AIE) only in improving patient reported outcomes in people with knee osteoarthritis. Design Multicentre, parallel group, superiority, statistician blinded, randomised (1:1; block; stratified; centralised web based) controlled trial. Setting Recruitment through general practices and the community in Cheshire, Manchester, North Tyneside, and Staffordshire, England; enrolment 25 November 2019 to 16 September 2022. Participants 466 adults aged ≥45 years with symptoms of knee osteoarthritis. Interventions AIE was delivered in one in-person consultation by a trained physiotherapist. Individuals randomised to the AIE+B group were also fitted with a patellofemoral, tibiofemoral unloading, or neutral stabilising knee brace, according to their predominant compartmental distribution of knee osteoarthritis, and were offered a two week follow-up consultation. Brief motivational interviewing with targeted text reminders supported brace adherence. Main outcome measures The primary outcome was a composite patient reported Knee Osteoarthritis Outcomes Score (KOOS)-5 (0-100) at six months after randomisation. Key secondary outcomes were KOOS-5 at three and 12 months, KOOS-5 subscale scores, and pain on weight bearing activity at three, six, and 12 months. Results 466 participants (mean age 64 (standard deviation 9) years; 46% female participants) were randomised, with 401 (86%), 394 (85%), and 370 (79%) participants followed up with analysable data at three, six, and 12 months, respectively. At six months, greater improvement in KOOS-5 was seen in the AIE+B group than in the AIE group (adjusted mean difference 3.39, 95% confidence interval (CI) 0.96 to 5.82; ... |