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
Qualifiers
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 design
Treatments tested in this trial
- Repair with DAA (dermal allograft augmentation)
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov