ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
Recruiting · NCT07224958 · Interventional (participants receive a specific treatment) · Lead sponsor: Rush University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Ossur Unloader One Knee Brace or Standard of CareROAM OA Single Upright Knee Brace
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.
Who can take part
Age range
40 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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:
Where it is running
1 location listed across 1 US state.
- Rush University Medical Center - Chicago, Illinois, United States