Evaluation of the MISHA Knee System for treating knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Weiss Orthopedics
  Sonoma, California, United States Recruiting
• Orthopaedics Specialists of NC
  Raleigh, North Carolina, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.