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Observational Study for Rotator Cuff Repair with Dermal Allograft Augmentation

This study is looking at how well large and massive rotator cuff tears heal after surgery, specifically when a dermal allograft augmentation (DAA) is used. A DAA is a special type of tissue graft from a donor that helps strengthen the repair. We want to compare the healing of repairs done with DAA to those done without it. You might be able to join if you are between 30 and 75 years old and need surgery for a full-thickness rotator cuff tear that is large or massive, and has some fatty infiltration (fat deposits) in the muscle. The main way we'll know if the repair is successful is by looking at MRI scans 26 weeks after surgery. This is an observational study, meaning we are watching and collecting information, not testing a new treatment.

Study design
This is an observational study planning to enroll 120 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for healing evaluation with an MRI at 26 weeks after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05981833

Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

UNKNOWN
Not specifiedAges 30–75Observational
Arthrex, Inc.
~120 participants
Updated 2025-02-24 on ClinicalTrials.gov
What's tested:Repair with DAA (dermal allograft augmentation)

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary outcome measure is healing evaluation in MRI
Measured over 26 Weeks

Conditions

Full-thickness Rotator Cuff Tear

Explore related trials

Rupture of rotator cuff of shoulder

NCT05981833

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Orthopaedic & Nuerosurgery Specialists

    Greenwich, Connecticutstudy coordinator listed

    Recruiting

  • Southern Oregon Orthopedics Research Foundation

    Medford, Oregonstudy coordinator listed

    Recruiting

  • Tennessee Orthopedic Foundation for Research Education and Research

    Nashville, Tennesseeno site contact published

    Recruiting

  • University of Arizona, Banner Health

    Scottsdale, Arizonano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Alicia Ruiz, MS · STUDY_DIRECTOR · Arthrex, Inc.

Who to contact

Caroline Caraci, BA
[email protected]
18009337001
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

The subject is between the ages of 30 and 75 years.
Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
Two complete RCTs or tear size equal to or greater than 3 cm in either the anterior-posterior or medial-lateral dimension
Primary rotator cuff repair
Stage II fatty infiltration or higher of the supraspinatus or infraspinatus muscle based on preoperative MRI6. Subject has a dual x-ray absorptiometry (DXA) or anterior posterior x-ray view of the target shoulder

Exclusion

The Subject is unable or unwilling to sign the patient informed consent, approved by the Institutional Review Board.
The subject objects to the use of allograft
Stage I or lower fatty infiltration of the supraspinatus AND infraspinatus muscle
Complete full-thickness subscapularis tears of greater than the superior one third of the tendon (Lafosse grade 3 and above)
Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
Recurrent shoulder instability
Corticosteroid injection in the operative shoulder within one month of surgery
Revision rotator cuff repair
Subject preoperative MRI obtained more than 12 months prior to surgery
Pregnant or planning to become pregnant during the study period
Workman's compensation case
Subject has conditions or circumstances that would interfere with study requirements.

What this trial measures

  • The primary outcome measure is healing evaluation in MRI26 Weeks

    MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification) MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)