Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

Study Overview
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Brief Summary
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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).

Detailed Description
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The primary objective is to evaluate postoperative healing of rotator cuff repair with and without DAA. Primary: The primary outcome measure is healing evaluation in MRI . MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification) Secondary: The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems, including: American Shoulder and Elbow Surgeons Score (ASES) Single Assessment Numeric Evaluation score (SANE) Visual Analog Scale (VAS) for pain Veterans RAND Health Survey (VR-12) Population: Males and females between the ages of 30 and 75 years that require surgery for large and massive rotator cuff tears Description of Treatment: Rotator cuff repair with or without augmentation using decellularized human dermal allograft.

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

Conditions
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Full-thickness Rotator Cuff Tear

Intervention / Treatment
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* Device: Repair with DAA (dermal allograft augmentation)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Repair without DAA<br>repaired without dermal allograft augmentation (DAA). | Device: Repair with DAA (dermal allograft augmentation)<br>* Patients undergo rotator cuff repair with dermal allograft augmentation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is healing evaluation in MRI | MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification) MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification) | 26 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems | 1. American Shoulder and Elbow Surgeons Score (ASES) A combination of objective measures and patient-reported outcomes, it measures pain and functional limitations in the shoulder. The objective questionnaire allows documentation of range of motion in the patient. | Preop, 26 Weeks, 1 Year, 2 Year | 
| Single Assessment Numeric Evaluation score (SANE) | Asks patients to rate shoulder pain as a percentage of normal. | Preop, 26 Weeks, 1 Year, 2 Year | 
| Visual Analog Scale (VAS) for pain | The standard measure for pain on a 0-10 scale, 10 being the worst. | Preop, two-week, six week, 26 Weeks, 1 Year, 2 Year | 
| Veterans RAND Health Survey (VR-12) | A self-administered health measure. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score, which provides an important contrast between the respondents' physical and psychological health status. | Preop, 26 Weeks, 1 Year, 2 Year |