MISHA® Post-Market Clinical Study

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118892
• Other study ID #: CP0009
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: July 30, 2030

Study information

• Verified date: April 2024
• Source: Moximed
• Contact: Rose Weinstein
• Phone: 5108873375
• Email: rsweinstein[@]moximed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 30, 2030
• Est. primary completion date: June 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Moximed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device- and procedure-related Subsequent Surgical Interventions		5 years post-implantation
Secondary	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
Secondary	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