ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
Recruiting now · Not applicable
Conditions studied: Knee Osteoarthritis
In brief
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.
Key facts
- Study ID
- NCT07224958
- Run by
- Rush University Medical Center
- People needed
- 30
- Starts
- 2026-04-27
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-05-12
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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:
Where it is running
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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