Abstract
Evidence is still inconclusive for the benefits of bracing in patients with knee osteoarthritis. To assess the effect of REBEL RELIEVER unloading knee brace in conservative treatment of knee osteoarthritis, a randomized controlled trial was conducted in 67 patients with symptomatic medial knee osteoarthritis, who randomly received 6-week treatment with either REBEL RELIVER unloading knee brace + usual care (Brace group, N = 32) or usual care alone (Control group, N = 35). Primary outcome was the global last 24h-pain relief (100-mm visual analogic scale [VAS]) at 6 weeks. Secondary endpoints included pain on motion (100-mm VAS), function (Lequesne index), safety and observance. At 6 weeks, mean [SD] last 24h-pain decreased significantly more in Brace group versus Control group (−41.35 [3.37] vs −15.37 [3.23], difference −25.98, 95% CI −41.64 to −10.33, P < 0.0001). Higher mean [SD] pain on motion decrease (−51.91 [3.49] vs −19.91 [3.34], difference −32.01, 95% CI −48.21 to −15.80, P < 0.0001) and better improvement of Lequesne index score (−5.8 [0.5] vs −2.3 [0.5], difference −3.5, 95% CI −5.0 to −2.0, P < 0.0001) were observed in Brace group. Safety and observance to the brace were excellent. The additive clinical benefit of wearing REBEL RELIEVER unloading knee brace was demonstrated in knee osteoarthritis patients.
Highlights
Knee osteoarthritis (OA) is a common medical condition that causes considerable pain and immobility, leading to functional disability and impaired quality of life
No brace-related adverse event (AE) leading to permanent treatment discontinuation was reported. The purpose of this randomized controlled trial was to assess the additive effect of a REBEL RELIEVER unloading knee brace in conservative treatment of medial OA
Results showed that combination of the REBEL RELIEVER unloading knee brace with usual care was superior to usual care alone in terms of improvement of last 24h-pain, pain on motion, functional disability, disease evolution assessed by both the patient and the investigator, and clinical response rate after a 6-week treatment period
Summary
Knee osteoarthritis (OA) is a common medical condition that causes considerable pain and immobility, leading to functional disability and impaired quality of life. The general purpose of unloading knee braces is to apply corrective forces by means of a three-point pressure system, which distribute load away from the damaged compartment. The aim of ROTOR study was to assess, in a randomized controlled trial, the additive effect of the REBEL RELIEVER unloading knee brace, which contains a patented Loadshifter Relief Mechanism for adjusting corrective forces (Fig. 1), in conservative treatment of medial OA. The ROTOR cohort consisted of patients with symptomatic medial knee OA who required management of persistent disabling pain. The brace applies corrective forces by means of a three-point pressure system. These corrective forces help distribute load away from the damaged compartment. The amount of corrective force can be increased as needed by making adjustments to the angle of the thigh shell
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