The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis

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Conditions studied: Medial Compartment Knee Osteoarthritis

In brief

Key facts

Study ID: NCT07439315
Run by: Icarus Medical Innovations
People needed: 150
Starts: 2026-03-01
Expected to finish: 2026-08-01
Last updated by the study team: 2026-02-27

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)
Self-reported pain score of less than 3 out of 10 in the medial compartment.
Varus or valgus deformity greater than 12°
Inability to read/write/communicate in English

Where it is running

Icarus Medical Innovations — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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