Evaluation of the MISHA Knee System for treating knee osteoarthritis
Post-Market Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis
NA · Moximed · NCT06118892
This study is testing a new knee treatment called the MISHA Knee System to see if it helps people with knee osteoarthritis feel less pain and improve their function over five years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Moximed (industry) |
| Locations | 3 sites (Sonoma, California and 2 other locations) |
| Trial ID | NCT06118892 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the MISHA Knee System in patients with osteoarthritis of the knee. It involves a prospective collection of data on various outcomes, including pain and function scores, satisfaction levels, and adverse events over a five-year period following the procedure. Participants will be monitored for device performance, including the rate of surgical site infections and the need for further surgical interventions. The study aims to provide insights into the long-term benefits and risks associated with this knee treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 25 to 65 with isolated medial compartment knee pain and a BMI under 35 who have not responded to non-operative treatments.
Not a fit: Patients with significant knee structural issues, such as large osteophytes or poor bone quality, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from knee osteoarthritis.
How similar studies have performed: Other studies have shown promising results with similar knee treatment approaches, indicating potential for success in this evaluation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sonoma, California and 2 other locations
- Weiss Orthopedics — Sonoma, California, United States (RECRUITING)
- Oregon Health and Science University — Portland, Oregon, United States (RECRUITING)
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Dennis Crawford, MD — Oregon Health and Science University
- Study coordinator: Rose Weinstein
- Email: rsweinstein@moximed.com
- Phone: (510) 887 3375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteo Arthritis Knee