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ROAM OA: Knee Braces for Unicompartmental Osteoarthritis

This study is comparing two knee braces for people with medial compartment knee osteoarthritis (OA), a type of arthritis affecting the inner part of the knee. Researchers want to see how the ROAM OA Single Upright Knee Brace compares to the Ossur Unloader One Knee Brace or standard care (no brace). They will look at how the braces affect knee movement during walking and how much pain you feel. You might be able to join if you are 40-85 years old, have been diagnosed with medial compartment knee OA, and experience walking pain. The study aims to understand which brace is better at reducing pain and improving how your knee works.

Study design
This is a single-center study planning to enroll 30 participants. It is a crossover study with a randomized control phase.
What's involved
You would wear an assigned knee brace for at least 4 hours a day for the duration of the study. Your knee movement and pain will be measured at the start, 4 weeks, and 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will assess changes in knee movement and pain over 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07224958

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

Recruiting
NAAges 40–85InterventionalTreatment
Rush University Medical Center
~30 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:ROAM OA Single Upright Knee BraceOssur Unloader One Knee Brace or Standard of Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in knee adduction moment during gait
Measured over Baseline, 4 weeks, and 8 weeks
+1 more outcome measured

Conditions

Knee Osteoarthritis

Explore related trials

Osteoarthritis of knee

NCT07224958

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Rush University Medical Center

    Chicago, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Markus Wimmer, PhD
[email protected]
3129422789
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in knee adduction moment during gaitBaseline, 4 weeks, and 8 weeks

    Change in peak knee adduction moment measured during gait analysis using instrumented motion capture and force platforms. Comparisons are made between baseline, 4 weeks, and 8 weeks.

  • Change in Visual Analog Scale (VAS) walking painBaseline, 4 weeks, and 8 weeks

    Change in walking pain measured by the Visual Analog Scale (VAS), in which participants rate their pain during walking along a 10-centimeter line ranging from 0 = no pain to 10 = worst imaginable pain. Lower scores indicate less pain and therefore a better outcome. Comparisons will be made between baseline, 4 weeks, and 8 weeks.