The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis (NCT07439315) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis
United States150 participantsStarted 2026-03-01
Plain-language summary
The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis
Who can participate
Age range30 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 30-70, as significant knee OA is very common for people under 30, and would be more likely correlated to trauma.
* Able to ambulate with or without assistive devices
* Body-mass index (BMI) under 35. This is to minimize the effect of the variable of how the brace fits on the patient. The finding of pain relief will extrapolate to any BMI.
* Willingness and ability to comply with scheduled visits and study procedures
* Willingness and ability to fill out patient questionnaires written in English
* Ability to provide informed consent
* Clinical diagnosis of medial or lateral compartment knee osteoarthritis requiring a KO.
* Subject is suitable for unilateral bracing
Exclusion Criteria:
* Significant cognitive impairment interfering with study assessments
* Active infections or wounds at the foot or leg
* Severe spasticity that limits brace fitting or functioning
* History of severe lower limb deformities that would preclude brace use
* History of major joint surgery or joint implants, such as total knee replacement
* Other neurological or musculoskeletal conditions unrelated to the lower limbs that significantly impact gait
* Non-ambulatory
* Inability to travel for study procedures or fill out required surveys
* Medical conditions of interest
* Pregnant women
* Prisoners
* Clinical diagnosis of knee osteoarthritis that is not specific to the knee's medial or lateral compartment (multicompartmental, or patellofemoral knee osteoarthritis)
* S…
What they're measuring
1
Knee Injury and Osteoarthritis Outcome Score (KOOS)