MISHA Post-Market Clinical Study

Launched by MOXIMED · Oct 31, 2023

Keywords

ClinConnect Summary

The MISHA® Post-Market Clinical Study is looking at the safety and effectiveness of the MISHA Knee System for people with osteoarthritis in their knees. This study will follow participants for five years after their procedure, collecting information on any complications, pain levels, function, and overall satisfaction with the device. Researchers will also measure things like movement ability and activity levels, as well as perform x-rays to check on the device's performance over time. The main goal is to see how many patients experience serious issues related to the device or the procedure after five years.

To join this study, participants need to be between 25 and 65 years old, have a body mass index (BMI) of less than 35, and experience knee pain that gets worse with activity. They should also have already tried other treatments for their osteoarthritis without success. However, those with certain conditions, like significant knee infections, instability, or poor bone quality, may not be eligible. If you decide to participate, you will be closely monitored over the five years to ensure your safety and to track how well the device works for you.

Gender

ALL

Eligibility criteria

• 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