Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT05981833
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).
Detailed 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.
Study:
NCT05981833
Study Brief:
Protocol Section:
NCT05981833