MISHA Post-Market Clinical Study (NCT06118892) | Clinical Trial Compass
RecruitingNot Applicable
MISHA Post-Market Clinical Study
United States120 participantsStarted 2023-11-03
Plain-language 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.
Who can participate
Age range25 Years – 65 Years
SexALL
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Inclusion criteria
✓. Subjects aged 25 to 65 years at time of index procedure
✓. Body Mass Index (BMI) of \< 35
✓. Activity exacerbated knee pain isolated to the medial compartment and not global in nature
✓. WOMAC pain ≥ 40
✓. Failed non-operative OA treatment
Exclusion criteria
✕. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device
✕. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)
✕. Ligamentous instability
✕. Active or recent knee infection
✕. Inflammatory joint disease, including sequalae of viral infections
✕. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
What they're measuring
1
Freedom from device- and procedure-related Subsequent Surgical Interventions