NCT05981833 Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
| NCT ID | NCT05981833 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Arthrex, Inc. |
| Condition | Full-thickness Rotator Cuff Tear |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-09-25 |
| Primary Completion | 2025-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-09-25 with a primary completion date of 2025-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Alicia Ruiz, MS
STUDY DIRECTOR
Arthrex, Inc.
Frequently Asked Questions
Who can join the NCT05981833 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Full-thickness Rotator Cuff Tear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05981833 currently recruiting?
Yes, NCT05981833 is actively recruiting participants. Contact the research team at caroline.caraci@arthrex.com for enrollment information.
Where is the NCT05981833 trial being conducted?
This trial is being conducted at Scottsdale, United States, Greenwich, United States, Medford, United States, Nashville, United States.
Who is sponsoring the NCT05981833 clinical trial?
NCT05981833 is sponsored by Arthrex, Inc.. The principal investigator is Alicia Ruiz, MS at Arthrex, Inc.. The trial plans to enroll 120 participants.