RECRUITING

Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-09-25

Study Completion:2026-09-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05981833

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.

Ages Eligible for Study:30 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Caroline Caraci, BA

CONTACT

18009337001

caroline.caraci@arthrex.com

Principal Investigator

Alicia Ruiz, MS

STUDY_DIRECTOR

Arthrex, Inc.

Study Locations (Sites)

Orthopaedic & Nuerosurgery Specialists

Greenwich, Connecticut, 06831

United States

Southern Oregon Orthopedics Research Foundation

Medford, Oregon, 97504

United States

Tennessee Orthopedic Foundation for Research Education and Research

Nashville, Tennessee, 37204

United States

Collaborators and Investigators

Sponsor: Arthrex, Inc.

Alicia Ruiz, MS, STUDY_DIRECTOR, Arthrex, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-25

Study Completion Date2026-09-15

Study Record Updates

Study Start Date2023-09-25

Study Completion Date2026-09-15

Terms related to this study

Additional Relevant MeSH Terms

Full-thickness Rotator Cuff Tear