MISHA Post-Market Clinical Study

Purpose

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.

Condition

  • Osteo Arthritis Knee

Eligibility

Eligible Ages
Between 25 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MISHA Knee System
  • Device: MISHA Knee System
    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.
    Other names:
    • Implantable Shock Absorber (ISA)

Recruiting Locations

Weiss Orthopedics
Sonoma, California 95476
Contact:
Noah Weiss

Orthopaedics Specialists of NC
Raleigh, North Carolina 27614
Contact:
Mark Galland, MD

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Dennis Crawford, MD

University of Virginia
Charlottesville, Virginia 22903
Contact:
David Diduch, MD

More Details

Status
Recruiting
Sponsor
Moximed

Study Contact

Rose Weinstein
(510) 887 3375
rsweinstein@moximed.com