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Recruiting
NCT06843980
MOTION Clinical Trial
Conditions: Osteoarthritis, Knee
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Moximed
Location: UC Davis Department of Orthopaedic Surgery Davis California
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT06843980). StuddyBuddy aggregates publicly available trial information.