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ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA

Who can join

Ages 40 to 85 · All sexes

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:

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About the study

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.

What is being tested

• ROAM OA Single Upright Knee Brace (device)
• Ossur Unloader One Knee Brace or Standard of Care (device)

Sponsor: Rush University Medical Center · Participants: 30 · Started: Apr 27, 2026

Contact the study team

• Markus Wimmer, PhD · Phone: 3129422789

Official record on ClinicalTrials.gov — NCT07224958

Locations in the U.S.

Conditions

• Knee Osteoarthritis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.