Effect of a valgus brace on medial tibiofemoral joint contact force in knee osteoarthritis with varus malalignment: A within-participant cross-over randomised study with an uncontrolled observational longitudinal follow-up

BACKGROUND: Previous investigations on valgus knee bracing have mostly used the external knee adduction moment. This is a critical limitation, as the external knee adduction moment does not account for muscle forces that contribute substantially to the medial tibiofemoral contact force (MTCF) during walking. The aims of this pilot study were to: 1) determine the effect of a valgus knee brace on MTCF; 2) determine whether the effect is more pronounced after 8 weeks of brace use; 3) assess the feasibility of an 8-week brace intervention. METHODS: Participants with medial radiographic knee OA and varus malalignment were fitted with an Össur Unloader One(©) brace. Participants were instructed to wear the brace for 8 weeks. The MTCF was estimated via an electromyogram-assisted neuromuscular model with and without the knee brace at week 0 and week 8. Feasibility outcomes included change in symptoms, quality of life, confidence, acceptability, adherence and adverse events. RESULTS: Of the 30 (60% male) participants enrolled, 28 (93%) completed 8-week outcome assessments. There was a main effect of the brace (p<0.001) on peak MTCF and MTCF impulse, but no main effect for time (week 0 and week 8, p = 0.10), and no interaction between brace and time (p = 0.62). Wearing the brace during walking significantly reduced the peak MTCF (-0.05 BW 95%CI [-0.10, -0.01]) and MTCF impulse (-0.07 BW.s 95%CI [-0.09, -0.05]). Symptoms and quality of life improved by clinically relevant magnitudes over the 8-week intervention. Items relating to confidence and acceptability were rated relatively highly. Participants wore the brace on average 6 hrs per day. Seventeen participants reported 30 minor adverse events over an 8-week period. CONCLUSION: Although significant, reductions in the peak MTCF and MTCF while wearing the knee brace were small. No effect of time on MTCF was observed. Although there were numerous minor adverse events, feasibility outcomes were generally favourable. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (12619000622101).