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New treatment option for Knee Osteoarthritis
Official title ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA
ClinicalTrials.gov ID: NCT07224958
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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: \-
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.