MISHA Post-Market Clinical Study
Recruiting
N/A
Interventional Study
Osteo Arthritis Knee
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 25 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Moximed · Industry
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About This Trial
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-procedur…
Trial Locations
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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. Lar…
Contacts