The aim of this study is to conduct a comparative evaluation of the ROAM OA Single Upright Brace and the Ossur Unloader One Knee Brace in subjects with medial compartment osteoarthritis. The focus is on comparing the immediate and short-term biomechanical effects of these braces on knee adduction moments and spatiotemporal gait parameters, as well as assessing the long-term efficacy of the ROAM OA brace in improving pain and functional outcomes for individuals with osteoarthritis.
Age 40-85 years.
BMI ≤ 35.
Physician-diagnosed medial compartment knee osteoarthritis.
Visual Analog Scale (VAS) walking pain ≥ 4.
Lateral or patellofemoral osteoarthritis.
Prior knee replacement.
Significant ligament injury or acute lower limb injury.
Neurological condition affecting gait.
Crossover
ROAM OA Single Upright Knee Brace
DeviceA commercially available single-upright knee brace designed to offload the medial compartment of the knee in patients with unicompartmental osteoarthritis; manufactured by Enovis. Participants will wear the brace daily for the duration of the study.
Ossur Unloader One Knee Brace or Standard of Care
DeviceParticipants will receive the Ossur Unloader One knee brace or no brace (standard of care) and will follow standard management and physical therapy guidelines. This group serves as the active comparator to the ROAM OA brace.
Change in knee adduction moment during gait
Change in peak knee adduction moment measured during gait analysis using instrumented motion capture and force platforms. Comparisons are made between baseline, 4 weeks, and 8 weeks.
Change in Visual Analog Scale (VAS) walking pain
Change in walking pain measured by the Visual Analog Scale (VAS), in which participants rate their pain during walking along a 10-centimeter line ranging from 0 = no pain to 10 = worst imaginable pain. Lower scores indicate less pain and therefore a better outcome. Comparisons will be made between baseline, 4 weeks, and 8 weeks.
Change in KOOS (Knee injury and Osteoarthritis Outcome Score) subscale scores
Change in scores on the KOOS questionnaire, which includes five subscales: Pain, Symptoms, Activities of Daily Living, Sports/Recreation, and Quality of Life. Each subscale is scored from 0 to 100, where 0 = extreme problems and 100 = no problems. Higher scores indicate better outcomes. Comparisons will be made between baseline, 4 weeks, and 8 weeks.
Change in knee range of motion (ROM)
Change in knee range of motion (flexion and extension) measured using goniometry; comparisons made between baseline, 4 weeks, and 8 weeks.
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Rush University Medical Center
Lead sponsor
Enovis
Collaborator
