Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

Description

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

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Study Overview

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Study Details

Study overview

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).

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

Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

Condition
Full-thickness Rotator Cuff Tear
Intervention / Treatment

-

Contacts and Locations

Greenwich

Orthopaedic & Nuerosurgery Specialists, Greenwich, Connecticut, United States, 06831

Medford

Southern Oregon Orthopedics Research Foundation, Medford, Oregon, United States, 97504

Nashville

Tennessee Orthopedic Foundation for Research Education and Research, Nashville, Tennessee, United States, 37204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

30 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arthrex, Inc.,

Alicia Ruiz, MS, STUDY_DIRECTOR, Arthrex, Inc.

Study Record Dates

2026-09-15