CuffMend™ Outcomes

Study Overview

Radiographic and Patient Reported Outcomes Following Arthroscopic Rotator Cuff Repair Using the CuffMend™ Augmentation Technique: A Prospective Clinical Study

Sponsor

Rush University Medical Center, Department of Orthopedic Surgery

Research Type

Prospective Case Series

Enrollment

23 enrolled, actively enrolling. Goal enrollment of 50 participants, ages 18 to 75 at the time of procedure.

Candidate Criteria

Patients with a 1 to 3 cm full-thickness rotator cuff tear who elect to have surgery. No more than 3 tendons torn, and the tear size cannot exceed 5 cm.

Purpose

To evaluate and compare radiographic and patient-reported outcomes following arthroscopic rotator cuff repair augmented with decellularized dermal allograft patch implanted using the CuffMend™ system, versus outcomes following arthroscopic rotator cuff repair without augmentation.

Study Design

A prospective case series with a 52-week minimum follow-up period, comparing standard MRI at pre op and 1 year post op. Patient-reported outcome assessments are collected preoperatively, and at 1 week, 6 weeks, 12 weeks, 24 weeks, 52 weeks (1 year), and 2 years post op.

Study Procedures

Preoperative shoulder MRI (non-contrast) and shoulder examination are performed. Informed consent is signed through Patient IQ, and surgery is scheduled within 21 days of consent.

1. Diagnostic arthroscopy to evaluate pathology
2. Arthroscopic augmented RCR using the CuffMend™ system
3. Office follow-ups at:
   • 1 week
   • 6 weeks
   • 12 weeks
   • 24 weeks
   • 52 weeks (with MRI at the same visit)
   • 102 weeks (with MRI at the same visit)