Comparing two knee braces for medial knee osteoarthritis

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

This test compares the ROAM OA brace and the Ossur Unloader One brace to see if they reduce pain and improve walking in people with medial knee osteoarthritis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Rush University Medical Center (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT07224958 on ClinicalTrials.gov

What this trial studies

This prospective, single-center crossover study first compares immediate and short-term biomechanical effects of the Enovis ROAM OA Single Upright Brace and the Ossur Unloader One on knee adduction moment and spatiotemporal gait parameters. Participants wear each brace while undergoing gait analysis, then enter a randomized controlled phase and extended follow-up focused on the ROAM OA brace to track pain and functional outcomes over time. Eligible adults are 40–85 with physician-diagnosed medial compartment OA, moderate walking pain, BMI ≤35, and the ability to walk 20 minutes unaided, and must agree to wear the assigned brace at least four hours per day. Study outcomes combine laboratory gait metrics with patient-reported pain and function measures to describe both biomechanical changes and clinical benefit.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40–85 with physician-diagnosed medial compartment knee osteoarthritis, a walking pain score of at least 4 on the VAS, BMI ≤35, able to walk 20 minutes unaided, and willing to wear a brace four or more hours per day.

Not a fit: Patients with lateral or patellofemoral-predominant OA, prior knee replacement, significant ligament or neurological conditions affecting gait, skin allergy to braces, or inability to tolerate wearing a brace are unlikely to benefit.

Why it matters

Potential benefit: If successful, the ROAM OA brace could reduce walking pain, improve gait mechanics and daily function, and potentially delay more invasive treatments.

How similar studies have performed: Unloading braces like the Ossur Unloader have shown short-term biomechanical unloading and symptomatic relief in prior studies, but long-term benefits are variable and the ROAM OA brace has limited independent long-term published data.

Eligibility criteria

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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Where this trial is running

Chicago, Illinois

• Rush University Medical Center — Chicago, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Markus Wimmer, PhD

Conditions Knee Osteoarthritis; knee brace; gait analysis