MISHA™ Post-Market Clinical Study

Study Overview
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Brief Summary
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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.

Official Title
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Post-Market Evaluation of the MISHA™ Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Device: MISHA Knee System


Participation Criteria
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Eligibility Criteria
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Key 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 Key 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 History of keloid, hypertrophic or contracture scaring Propensity for restrictive scar formation or adhesions with prior procedures

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MISHA Knee System<br> | Device: MISHA Knee System<br>* The MISHA Knee System is an extra-capsular knee implant intended to reduce loads on the medial knee. The implant consists of an absorber located between bases fixed with locking screws to the medial cortices of the distal femur and proximal tibia. The implant shares the load with the medial knee joint and articulating ball-and-sockets allow the device to accommodate the natural motions of the knee.<br>* Other names: Implantable Shock Absorber (ISA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device- and procedure-related Subsequent Surgical Interventions |  | 5 years post-implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Pain | Percent of subjects meeting clinically meaningful improvement (defined as ≥ 10-point change from baseline) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for evaluation of pain. The responses to each question are summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems. | 5 years | 
| WOMAC Function | Percent of subjects meeting clinically meaningful improvement (defined as ≥ 10-point change from baseline). Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for evaluation of function. The responses to each question are summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems. | 5 years |