Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
ConditionFull-thickness Rotator Cuff Tear
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-75
SponsorArthrex, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Males and females between the ages of 30 and 75 years that require surgery for large and massive rotator cuff tears
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Repair with DAA (dermal allograft augmentation)
DevicePatients undergo rotator cuff repair with dermal allograft augmentation.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Repair without DAA1 intervention
Trial outcomes
Primary outcomes
1
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 WeeksSecondary outcomes
1
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 Year2
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 Year3
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 Year4
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 YearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov