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NCT06843980 | RECRUITING | Osteoarthritis, Knee

MOTION Clinical Trial
Sponsor:

Moximed

Brief Summary:

Prospective, multicenter, two-arm, 2:1 randomized controlled trial (RCT) comparing the benefits in subjects with medial knee osteoarthritis who are treated with either the MISHA Knee System or with non-surgical treatment. This is the first randomized head-to-head study comparing outcomes from subjects treated with the MISHA Knee System.

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

MISHA Knee System

Non-Surgical Treatment

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : SINGLE
Masking Description : Randomization is programmed within the Electronic Data Capture system to ensure that the groups are unbiased and that the results are reliable, independent from the participant, investigator, and sponsor. The outcomes assessor remains independent from the participant, investigator and the sponsor.
Primary Purpose : TREATMENT
Official Title : Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis Versus the Use of Non-surgical Treatment: Randomized Clinical Trial and Comparison of Therapies for Medial Knee Osteoarthritis
Actual Study Start Date : 2025-02-13
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2029-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • 1. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
  • 2. WOMAC pain ≥ 40
  • 3. Failed to find relief in non-surgical treatment modalities
  • Key Exclusion Criteria
    • 1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
    • 2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
    • 3. Ligamentous instability
    • 4. Active or recent knee infection
    • 5. Inflammatory joint disease, including sequelae of viral infections
    • 6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
    • 7. History of keloid, hypertrophic or contracture scaring
    • 8. Propensity for restrictive scar formation or adhesions with prior procedures
MOTION Clinical Trial

Location Details

NCT06843980

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

UC Davis Department of Orthopaedic Surgery

Davis, California, United States, 95816

RECRUITING

United States, California

Scripps Clinic Jefferson

Oceanside, California, United States, 92054

RECRUITING

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, Ohio

Ohio State Jameson Crane Sports Medicine Institute

Columbus, Ohio, United States, 43202