Comparing two knee braces for medial knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rush University Medical Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Markus Wimmer, PhD
• Email: markus_a_wimmer@rush.edu
• Phone: 3129422789

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.