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MISHA™ Post-Market Clinical Study

Sponsor
Moximed (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06118892
Collaborator
(none)
120
Enrollment
1
Location
1
Arm
73.8
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: MISHA Knee System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post-Market Evaluation of the MISHA™ Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis
Anticipated Study Start Date :
Nov 6, 2023
Anticipated Primary Completion Date :
Dec 30, 2029
Anticipated Study Completion Date :
Dec 30, 2029

Arms and Interventions

Arm Intervention/Treatment
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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Freedom from device- and procedure-related Subsequent Surgical Interventions [5 years post-implantation]

    Secondary Outcome Measures

    1. WOMAC Pain [5 years]

      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.

    2. WOMAC Function [5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Wexner Medical Center Columbus Ohio United States 43202

    Sponsors and Collaborators

    • Moximed

    Investigators

    • Principal Investigator: David Flanigan, MD, The Ohio State University Wexner Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Moximed
    ClinicalTrials.gov Identifier:
    NCT06118892
    Other Study ID Numbers:
    • CP0009
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 9, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Nov 9, 2023