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NCT Number: NCT07439315

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

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

Not Yet Recruiting

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Key information

Conditions

Medial Compartment Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icarus Medical Innovations

Charlottesville, Virginia, 22902, United States

Location contact

Ben Koerber

CONTACT

[email protected]

8147909364

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medial joint distraction brace

Device

Patients will receive Icarus Adonis Joint Distraction brace.

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Baseline, 2, 4, 8, 12 weeks

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

  2. European Quality of Life-5 Dimensions (EQ-5D-5L)

    Time frame: Baseline, 2, 4, 8, 12 weeks.

    0 to 1, where 1 is perfect health

  3. Visual Analogue Scale (VAS)

    Time frame: Baseline, 2, 4, 8, 12 weeks.

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

  4. Functional Mobility Assessments

    Time frame: Baseline, 2, 4, 8, 12 weeks

    6 minute walk test

  5. Functional Mobility Assessment

    Time frame: Baseline, 2, 4, 8, 12 weeks

    5 times Sit to Stand test

  6. Functional Mobility Assessment

    Time frame: Baseline, 2, 4, 8, 12 weeks

    Timed Up and Go test

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin M Koerber, PhD

CONTACT

[email protected]

8147909364

Evan Eckersley

CONTACT

[email protected]

(570) 955-9662

Sponsors and collaborators

Lead sponsor

Icarus Medical Innovations

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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