150 patients with Kellgren-Lawrence or Ahlback grade I-II knee osteosrthritis were randomized to either an active or placebo unloader brace. Patients were followed for 52 weeks for outcome related to patient-reported function on the Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcome Score (KOOS). In general, changes from baseline to 52 weeks in scores were greater in the unloader brace group compared to placebo brace group, with statistical significance demonstrated for the KOOS pain, sport/rec, and QoL subscales. However, difference between groups was deemed clinically relelvant only for the KOOS sport/rec subscale.