NCT05981833 · Arthrex, Inc.
Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
What this study is about
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).
View original scientific 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Scottsdale, Arizona
- Greenwich, Connecticut
- Medford, Oregon
- Nashville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 24, 2025 · Source of record for eligibility and locations