MISHA™ Randomized Study

Study Overview

Evaluation of the MISHA® Knee System for Symptom Relief in Subjects with Medial Knee Osteoarthritis versus Non Surgical Treatment: Randomized Assessment and Comparison of Therapies for Medial Knee Osteoarthritis

Sponsor

Rush University Medical Center, Department of Orthopedic Surgery. Industry sponsor: Moximed.

Research Type

Prospective, multicenter, two-arm, 2:1 randomized controlled trial

Enrollment

9 enrolled, actively enrolling.

Candidate Criteria

Male or female patients with medial compartment knee osteoarthritis and knee pain who have failed non-surgical treatment and are unwilling or ineligible for total knee replacement.

Purpose

To compare symptom relief and functional outcomes in patients with medial knee osteoarthritis treated with the MISHA Knee System versus non-surgical treatment.

Study Design

A prospective randomized clinical study comparing MISHA Knee System implantation to non-surgical treatment. Subjects in the non-surgical arm may cross over to MISHA after completing the six-month endpoint visit, and before the twenty-four-month visit.

Study Procedures

Baseline assessment and confirmation of eligibility, followed by randomization and follow-up assessments. Outcomes tracked include WOMAC pain, WOMAC function, subject activity, range of motion, radiographic implant integrity, adverse events, and subsequent surgical interventions.

1. Baseline evaluation and confirmation of eligibility
2. Randomization to one of two arms:
   • MISHA Knee System arm
   • Non-surgical treatment arm
3. Office follow-ups at:
   • 6 weeks
   • 3 months
   • 6 months
   • 12 months
   • 24 months
4. Crossover subjects restart the same follow up schedule after MISHA implantation