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).
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 Type
OBSERVATIONAL
Enrollment
120
Patients undergo rotator cuff repair with dermal allograft augmentation.
University of Arizona, Banner Health
Scottsdale, Arizona, United States
RECRUITINGOrthopaedic & Nuerosurgery Specialists
Greenwich, Connecticut, United States
RECRUITINGSouthern Oregon Orthopedics Research Foundation
Medford, Oregon, United States
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)
Time frame: 26 Weeks
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.
Time frame: Preop, 26 Weeks, 1 Year, 2 Year
Single Assessment Numeric Evaluation score (SANE)
Asks patients to rate shoulder pain as a percentage of normal.
Time frame: 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.
Time frame: 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.
Time frame: Preop, 26 Weeks, 1 Year, 2 Year
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Tennessee Orthopedic Foundation for Research Education and Research
Nashville, Tennessee, United States
RECRUITING