Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

Arthrex

Status

Enrolling

Conditions

Full-thickness Rotator Cuff Tear

Treatments

Device: Repair with DAA (dermal allograft augmentation)

Study type

Observational

Funder types

Industry

Identifiers

NCT05981833

AIRR-0094

Details and patient eligibility

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).

Full description

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.

Enrollment

120 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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.