Recruiting

Dermal Allograft

Sponsor:

Arthrex, Inc.

Code:

NCT05981833

Conditions

Full-thickness Rotator Cuff Tear

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Repair with DAA (dermal allograft augmentation)

Study Details

Brief 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).

Conditions

Full-thickness Rotator Cuff Tear

Study ID

NCT05981833

Start date

Sep 25, 2023

Status verified date

Mar, 2024

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Sep 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Intraoperative exclusion criteria:

Partial rotator cuff repairs

Lafosse grade 3 or higher subscapularis tears

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Repair without DAA

repaired without dermal allograft augmentation (DAA).

Interventions

Repair with DAA (dermal allograft augmentation)

Patients undergo rotator cuff repair with dermal allograft augmentation.

Primary outcome measure

  • The primary outcome measure is healing evaluation in MRI [ Time Frame: 26 Weeks ]

Central Contacts and Locations

Central contacts

Caroline Caraci, BA

18009337001caroline.caraci@arthrex.com

Locations

University of Arizona, Banner Health

Recruiting

Scottsdale, Arizona, United States, 85006

Principal Investigator:

Anup Shah, MD

Orthopaedic & Nuerosurgery Specialists

Recruiting

Greenwich, Connecticut, United States, 06831

Contacts

Paul Sethi, MD

2038691145

Principal Investigator:

Paul Sethi, MD

Southern Oregon Orthopedics Research Foundation

Recruiting

Medford, Oregon, United States, 97504

Contacts

Patrick Denard

5416082595

Principal Investigator:

Patrick Denard, MD

Tennessee Orthopedic Foundation for Research Education and Research

Recruiting

Nashville, Tennessee, United States, 37204

Principal Investigator:

Paul Brady, MD

More Information

Sponsor

Arthrex, Inc.

Last update posted

Feb 24, 2025

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arthrex, Inc. on 2025-02-24.