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The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis | Clinical Trials | Clareo Health

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

NCT07439315•Icarus Medical Innovations

View on ClinicalTrials.gov

Summary

Eligibility

Age

30 - 70 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (1)

Icarus Medical Innovations

Charlottesville, Virginia, United States

Key Dates

Start Date

March 1, 2026

Primary Completion Date

June 1, 2026

Completion Date

August 1, 2026

Last Updated

February 27, 2026

Enrollment

150

ESTIMATED participants

Conditions

Medial Compartment Knee Osteoarthritis

Interventions

Medial joint distraction brace

DEVICE

Contacts

Benjamin M Koerber, PhD

CONTACT

8147909364 benk@icarusmedical.com

Evan Eckersley

CONTACT

(570) 955-9662 evan@icarusmedical.com

Study of How An Ankle Strap Changes Effects of Insole Treatment for Knee Osteoarthritis

NCT00331110

Medial Compartment Knee Osteoarthritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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