Actively Recruiting
ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
Led by Rush University Medical Center · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
Sponsors
R
Rush University Medical Center
Lead Sponsor
E
Enovis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40-85 years
- Body Mass Index (BMI) of 35 or less
- Diagnosed with medial compartment knee osteoarthritis by a physician
- Walking pain score of 4 or greater on the Visual Analog Scale (VAS)
- Willing to wear the assigned knee brace at least 4 hours per day
- Able to walk independently for at least 20 minutes without assistance
- Using a stable pain medication regimen for at least 4 weeks
- At least 3 months since last hyaluronic acid, platelet-rich plasma, or steroid injection
You will not qualify if you...
- Presence of lateral or patellofemoral osteoarthritis
- Previous knee replacement surgery
- Significant ligament injury or acute lower limb injury
- Neurological conditions that affect walking
- Severe psychiatric or neurological disorders affecting pain perception
- Skin conditions or allergies that prevent use of a knee brace
- Currently using another knee brace or assistive device
- Recent use of opioids or corticosteroids within the last 4 weeks
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
M
Markus Wimmer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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