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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Oregon
Oregon Health and Science University
RECRUITING
Portland
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Rose Weinstein
rsweinstein@moximed.com
5108873375
Backup
Vijaya Krishnamoorthy
vkrishnamoorthy@moximed.com
5108873328
Time Frame
Start Date: 2023-11-03
Estimated Completion Date: 2030-07-30
Participants
Target number of participants: 120
Treatments
Experimental: MISHA Knee System
Related Therapeutic Areas
Sponsors
Leads: Moximed

This content was sourced from clinicaltrials.gov