The effectiveness of the UniReliever offloading knee brace for treating medial knee osteoarthritis: A randomized clinical trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: Offloading knee braces can reduce pain and improve mobility in patients with knee osteoarthritis. OBJECTIVES: 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. METHODS: 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/m 2 , 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Clinical Trials NCT05905809.
Authors: Michael Benning, Stéphanie Villet, Alyssia Marques, Ralf-Dieter Hilgers
Institutions: Sigmund Freud Privatuniversität Wien, RWTH Aachen University
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4416934633