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COMPLETED
NCT07890831
NA

Dermis on Demand Allograft Augmentation for Rotator Cuff Repair

Sponsor: University of Cincinnati

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether adding a human acellular dermal allograft (Dermis on Demand) during arthroscopic rotator cuff repair improves tendon-to-bone healing and lowers the rate of re-tear compared to standard repair alone. Sixty adults with large (3-5 cm) full-thickness superior or posterosuperior rotator cuff tears will be randomly assigned to repair with or without the allograft. Healing will be assessed by MRI at 12 months and by ultrasound at 6 months after surgery. Patient-reported outcomes, shoulder range of motion and strength, and operative time will also be compared between the groups.

Official title: A Randomized Control Trial Assessing the Efficacy of the Dermis on Demand for Rotator Cuff Repair

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-12-02

Completion Date

2026-05-15

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

PROCEDURE

Arthroscopic rotator cuff repair; Biological: Dermis on Demand

Arthroscopic knotless double-row transosseous-equivalent rotator cuff repair augmented with 2-3 Dermis on Demand acellular dermal allograft pieces loaded onto lateral-row suture tapes

PROCEDURE

Arthroscopic rotator cuff repair

A human acellular dermal allograft (CellRight Technologies) with a cannulated design, loaded onto suture tape and compressed onto the repaired footprint during lateral-row anchor seating. Other names: DOD; acellular dermal allograft.

Locations (1)

University of Cincinnati / UC Health Orthopaedics & Sports Medicine

Cincinnati, Ohio, United States