MISHA® Post-Market Clinical Study

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06118892
Study type	Interventional
Source	Moximed
Contact	Rose Weinstein
Phone	5108873375
Email	rsweinstein@moximed.com
Status	Recruiting
Phase	N/A
Start date	November 3, 2023
Completion date	July 30, 2030

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