The effectiveness of the UniReliever offloading knee brace for treating medial knee osteoarthritis: A randomized clinical trial.

Abstract

Offloading knee braces can reduce pain and improve mobility in patients with knee osteoarthritis. This study aimed to determine the effectiveness of the new UniReliever knee brace and to compare it to the widely used Unloader One X device. In this open-label, three-arm parallel-group randomized trial, 60 patients with medial knee osteoarthritis (Kellgren-Lawrence grade II‒IV), 34 male and 26 female with a mean age of 69.62 ± 9.57 years and mean body mass index of 26.86 ± 3.18 kg/m2, were recruited from an orthopedic center. The patients were randomly allocated to receive a UniReliever device, an Unloader One X device, or no knee brace (control). The primary outcome was the change in the pain-free walking distance from baseline to 6 weeks. Other measures included the Lequesne index, pain on exertion, range of motion, and analgesic use. The mean pain-free walking distance more than doubled for the UniReliever group (from 2.0 ± 1.4 km to 4.6 ± 3.4 km) and the Unloader One X group (from 2.6 ± 2.3 to 5.6 ± 3.7 km), but not for the controls (from 1.3 ± 1.2 to 1.4 ± 1.3 km; comparisons with controls: p < 0.0001). The Lequesne index and pain on exertion also improved for the 2 knee brace groups (p < 0.05 for all comparisons with controls; p > 0.05 for comparisons between the knee brace groups), and the use of analgesics fell (UniReliever: 4/7 patients; Unloader One X: 8/11 patients; whereas controls: 1/9 patients). There were no serious adverse events. The UniReliever offloading knee brace can improve mobility and reduce pain in patients with medial knee osteoarthritis. The benefits are similar compared with the Unloader One X. Clinical Trials NCT05905809.