ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
Key facts
- Who runs it
- Rush University Medical Center
- Where
- Chicago, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 30 people, planned
- Started
- 27 Apr 2026
- Expected to end
- Apr 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- ROAM OA Single Upright Knee Brace
- Ossur Unloader One Knee Brace or Standard of Care
- Record updated
- 12 May 2026
Who can take part
- Age
- 40 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior knee replacement
- Recent opioid or corticosteroid use (<4 weeks)
- Neurological condition affecting gait
- Severe psychiatric or neurological disorder affecting pain perception
- Skin condition or allergy preventing brace use
- Lateral or patellofemoral osteoarthritis
- Significant ligament injury or acute lower limb injury
- Current use of another brace or assistive device
- Pregnant
- -
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 85 years old?
Where in United States
- Rush University Medical CenterChicago, United StatesContact: Christopher Knowlton, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ROAM OA braceTreatment being tested
Participants receive the ROAM OA Single Upright Knee Brace (Enovis) to wear daily for the study duration. The brace is designed to offload the medial compartment of the knee and improve pain and function.
Treatment: ROAM OA Single Upright Knee Brace
- Active Comparator: Unloader brace or standard of careExisting treatment, for comparison
Participants receive the Ossur Unloader One knee brace or no brace (standard of care) and will follow standard pain management and physical therapy guidelines. This group serves as an active comparator to the ROAM OA brace.
Treatment: Ossur Unloader One Knee Brace or Standard of Care
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07224958, who can take part
- Record updated
- 12 May 2026