RecruitingNot ApplicableNCT07224958

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


Sponsor

Rush University Medical Center

Enrollment

30 participants

Start Date

Apr 27, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Ossur Unloader One Knee Brace or Standard of Care and a medical device called ROAM OA Single Upright Knee Brace for people with knee osteoarthritis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 40 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEROAM OA Single Upright Knee Brace

A commercially available single-upright knee brace designed to offload the medial compartment of the knee in patients with unicompartmental osteoarthritis; manufactured by Enovis. Participants will wear the brace daily for the duration of the study.

DEVICEOssur Unloader One Knee Brace or Standard of Care

Participants will receive the Ossur Unloader One knee brace or no brace (standard of care) and will follow standard management and physical therapy guidelines. This group serves as the active comparator to the ROAM OA brace.


Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT07224958


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