ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
NCT07224958
Summary
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.
Eligibility
Inclusion Criteria: * Inclusion Criteria: * Age 40-85 years. * BMI ≤ 35. * Physician-diagnosed medial compartment knee osteoarthritis. * Visual Analog Scale (VAS) walking pain ≥ 4. * Willing to wear assigned brace ≥ 4 hours/day. * Able to walk independently for 20 minutes unaided. * Stable pain medication regimen ≥ 4 weeks. * ≥3 months since last hyaluronic acid (HA), platelet-rich plasma (PRP), or steroid injection. Exclusion Criteria: * Lateral or patellofemoral osteoarthritis. * Prior knee replacement. * Significant ligament injury or acute lower limb injury. * Neurological condition affecting gait. * Severe psychiatric or neurological disorder affecting pain perception. * Skin condition or allergy preventing brace use. * Current use of another brace or assistive device. * Recent opioid or corticosteroid use (\<4 weeks). * Pregnant. Exclusion Criteria: \-
Conditions2
Locations1 site
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NCT07224958