9
Participants
Start Date
July 1, 2018
Primary Completion Date
June 30, 2024
Study Completion Date
June 30, 2024
ArthroFLEX ECM scaffold graft
In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.
Control
This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.
Alternative Treatment Group
Patients who meet pre-op inclusion criteria where a repair cannot be accomplished due to intraoperative findings will remain in the study. This group will be analyzed separately and still follow study procedures.
Cleveland Clinic Florida, Weston
Collaborators (1)
LifeNet Health
INDUSTRY
The Cleveland Clinic
OTHER
Gregory Gilot
OTHER