The purpose of this study is to see how well the ActiveMatrix® graft works at improving healing and function of the shoulder following rotator cuff repair surgery
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
1-2 tendon full thickness reparable rotator cuff tendon tear(s)
Failed conservative medical management of the rotator cuff tendon tear defined as: 4-6 weeks of formal physical therapy or guided home exercises and activity modification
Prior surgery on the index shoulder within 12 months of enrollment, including Latarjet procedures, superior labral treat from anterior to posterior (SLAP), and (failed) primary rotator cuff surgery,
Prior surgery for bone defects requiring bone implantation in the index shoulder,
Steroid injection into the index shoulder within 6 weeks of enrollment.
Subscapularis tear greater than 1/3 of tendon involvement requiring repair,
The University of Texas Health Science Center, Houston
Lead sponsor
Skye Biologics Holdings, LLC
Collaborator