ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
Rush University Medical Center
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.
Description
INTRODUCTION The Enovis ROAM OA outcomes study is a prospective, single-center, crossover study with a subsequent randomized control phase and extended follow-up gait analysis, intended to evaluate the efficacy of the ROAM OA knee brace in subjects with medial knee osteoarthritis (OA). The purpose 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 OA. The focus is on comparing the immediate and short-term biomechanical effects of these braces on knee adduction moments and spatiotemp…
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
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 aff…
Interventions
- DeviceROAM OA Single Upright Knee Brace
A 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.
- DeviceOssur Unloader One Knee Brace or Standard of Care
Participants 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.
Location
- Rush University Medical CenterChicago, Illinois