NCT07224958 · Rush University Medical Center
ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
ROAM 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.
DEVICE
Ossur 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.
Primary outcome measures
Change in knee adduction moment during gait
Time frame: Baseline, 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 pain
Time frame: Baseline, 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 40-85 years.
- 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: \-
Where
- Chicago, Illinois
Collaborators
Enovis
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations