MISHA Post-Market Clinical Study

Moximed120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Osteo Arthritis Knee

Interventions

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

Weiss Orthopedics

Sonoma, California, United States

RECRUITING

Orthopaedics Specialists of NC

Raleigh, North Carolina, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

Freedom from device- and procedure-related Subsequent Surgical Interventions

Time frame: 5 years post-implantation

Secondary Outcomes

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.

Time frame: 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.

Time frame: 5 years

MISHA Post-Market Clinical Study

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts