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Study of Icarus Adonis Joint Distraction Brace for Knee Osteoarthritis

This study is testing a new device called the Icarus Adonis Joint Distraction brace for people with medial compartment knee osteoarthritis (wear and tear in the inner part of the knee joint). Researchers want to see if this brace can help reduce pain and improve quality of life. You might be able to join if you are between 30 and 70 years old, can walk with or without help, and have a BMI (Body Mass Index) under 35. The study will measure changes in your knee pain and how it affects your daily life over 12 weeks. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 150 participants. The phase of the study is not specified.
What's involved
Participants will receive the Icarus Adonis Joint Distraction brace. Measurements will be taken at baseline, 2, 4, 8, and 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07439315

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

Not Yet Recruiting
NAAges 30–70InterventionalTreatment
Icarus Medical Innovations
~150 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Medial joint distraction brace

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured over Baseline, 2, 4, 8, 12 weeks
+5 more outcomes measured

Conditions

Medial Compartment Knee Osteoarthritis

Explore related trials

Osteoarthritis of knee

NCT07439315

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Icarus Medical Innovations

    Charlottesville, Virginiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Benjamin M Koerber, PhD
[email protected]
8147909364
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)Baseline, 2, 4, 8, 12 weeks

    Scored 0 to 100, where 0 represents total knee disability and 100 represents perfect knee

  • European Quality of Life-5 Dimensions (EQ-5D-5L)Baseline, 2, 4, 8, 12 weeks.

    0 to 1, where 1 is perfect health

  • Visual Analogue Scale (VAS)Baseline, 2, 4, 8, 12 weeks.

    0-100, zero meaning no pain, 10 meaning severe pain

  • Functional Mobility AssessmentsBaseline, 2, 4, 8, 12 weeks

    6 minute walk test

  • Functional Mobility AssessmentBaseline, 2, 4, 8, 12 weeks

    5 times Sit to Stand test

  • Functional Mobility AssessmentBaseline, 2, 4, 8, 12 weeks

    Timed Up and Go test