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NCT06118892 | RECRUITING | Osteo Arthritis Knee

MISHA® Post-Market Clinical Study
Sponsor:

Moximed

Brief Summary:

Prospective evaluation of the safety and effectiveness of the MISHA Knee System. The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedure. The primary analysis of this study is freedom from device- and procedure-related SSIs at five (5) years post-implantation. This study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years. Study subjects will be followed over a five-year post-implant period.

Condition or disease

Osteo Arthritis Knee

Intervention/treatment

MISHA Knee System

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Post-Market Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis
Actual Study Start Date : 2023-11-03
Estimated Primary Completion Date : 2030-06-30
Estimated Study Completion Date : 2030-07-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 25 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • 1. Subjects aged 25 to 65 years at time of index procedure
  • 2. Body Mass Index (BMI) of \< 35
  • 3. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
  • 4. WOMAC pain ≥ 40
  • 5. Failed non-operative OA treatment
  • 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 sequalae 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
MISHA® Post-Market Clinical Study

Location Details

NCT06118892

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, Ohio

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43202

RECRUITING

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903