Trial reportProsthetics and orthotics international2026
The effectiveness of the UniReliever offloading knee brace for treating medial knee osteoarthritis: A randomized clinical trial.
Trial report in Prosthetics and orthotics international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05905809 (Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis), which is not on this map. Not yet cited in PubMed.
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Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOffloading knee braces can reduce pain and improve mobility in patients with knee osteoarthritis.
objectivesThis study aimed to determine the effectiveness of the new UniReliever knee brace and to compare it to the widely used Unloader One X device.
methodsIn 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.
resultsThe 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.
conclusionsThe 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 registrationClinical Trials NCT05905809.
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