Actively Recruiting
MISHA Post-Market Clinical Study
Led by Moximed · Updated on 2026-04-01
120
Participants Needed
3
Research Sites
351 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MISHA Post-Market Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 25 to 65 years at time of index procedure
- Body Mass Index (BMI) less than 35
- Knee pain worsened by activity and isolated to the medial compartment
- WOMAC pain score of 40 or higher
- Failed non-operative treatment for osteoarthritis
You will not qualify if you...
- Large medial osteophytes or significant meniscus extrusion interfering with device placement or function
- Poor bone quality such as erosion, osteopenia, or osteoporosis
- Ligament instability in the knee
- Active or recent infection in the knee
- Inflammatory joint diseases including viral infection consequences
- Known or suspected allergy to cobalt, chromium, nickel, or other metals
- History of keloid, hypertrophic, or contracture scarring
- Tendency for restrictive scar formation or adhesions from previous procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Weiss Orthopedics
Sonoma, California, United States, 95476
Actively Recruiting
2
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
3
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
R
Rose Weinstein
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here