Comparing a new knee treatment to non-surgical options for 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 clinical trial is a prospective, multicenter, two-arm randomized controlled trial that aims to compare the effectiveness of the MISHA Knee System against non-surgical treatments in patients suffering from medial knee osteoarthritis. Participants will be randomly assigned to receive either the MISHA Knee System or standard non-surgical treatment, with outcomes measured to determine which approach provides better relief from knee pain. This is the first head-to-head study specifically evaluating the MISHA Knee System in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Scripps Clinic Jefferson
  Oceanside, California, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting
• Genesis Orthopedics & Sports Medicine
  Oak Brook, Illinois, United States Recruiting
• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• Ohio State Jameson Crane Sports Medicine Institute
  Columbus, Ohio, United States Recruiting
• UT Health San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Rose S 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.