Could a simple brace ease knee arthritis without surgery?
NCT ID NCT07439315
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special brace designed to gently distract (separate) the knee joint, aiming to reduce pain and improve function in people with medial knee osteoarthritis. Researchers will enroll 150 adults aged 30-70 with a BMI under 35. Participants will wear the brace and be assessed for pain, quality of life, and mobility over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Icarus Adonis Joint Distraction brace (a medical device)
- What this could lead to
- If it works, this brace could offer a non-surgical way to reduce knee pain and improve mobility for people with osteoarthritis.
- What could go wrong
- This is an early-stage trial with no results yet. The brace may not provide lasting relief, and benefits may vary by individual.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Icarus Medical Innovations
Charlottesville, Virginia, 22902, United States
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