No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Rush University Medical Center · Other
Who this trial is looking for
This trial is looking for people aged 40 to 85 with knee osteoarthritis. Participants will wear one of two knee braces to see how it affects their pain and walking.
Are You a Good Fit for This Trial?
Must not be takingOpioidsCorticosteroids
You may be able to join if
I am between 40 and 85 years old.
I have been diagnosed with medial compartment knee osteoarthritis.
I have walking pain rated at 4 or higher.
I can walk independently for 20 minutes.
I can wear the brace for at least 4 hours a day.
I have been on a stable pain medication for at least 4 weeks.
It has been at least 3 months since my last injection treatment.
You may not be able to join if
I have lateral or patellofemoral osteoarthritis.
I have had a knee replacement.
I have a significant ligament injury or an acute injury in my leg.
I have a neurological condition that affects my walking.
I have a severe psychiatric or neurological disorder that affects my pain perception.
I have a skin condition or allergy that prevents me from using a brace.
I currently use another brace or assistive device.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Status
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 med…
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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