RecruitingNCT05981833

Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

A Randomized, Post-market Study Evaluating Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears


Sponsor

Arthrex, Inc.

Enrollment

120 participants

Start Date

Sep 25, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation (DAA).


Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares rotator cuff repair surgery with and without the addition of a dermal allograft — a piece of processed human donor skin used to reinforce the repair — for people with large or massive rotator cuff tears and significant muscle deterioration (fatty infiltration). The goal is to determine whether adding the allograft patch improves tendon healing, as seen on MRI, and whether it reduces pain and improves shoulder function. Adults aged 30–75 with a large rotator cuff tear confirmed on MRI, significant fatty infiltration of the rotator cuff muscles, and no prior major shoulder surgery are eligible. Participation involves undergoing arthroscopic rotator cuff repair (with or without the allograft) and completing shoulder function questionnaires and follow-up MRI scans after surgery. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERepair with DAA (dermal allograft augmentation)

Patients undergo rotator cuff repair with dermal allograft augmentation.


Locations(4)

University of Arizona, Banner Health

Scottsdale, Arizona, United States

Orthopaedic & Nuerosurgery Specialists

Greenwich, Connecticut, United States

Southern Oregon Orthopedics Research Foundation

Medford, Oregon, United States

Tennessee Orthopedic Foundation for Research Education and Research

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT05981833