A Prospective, Single Blind, Multi-Center, Randomized, Controlled, Pivotal Study to Evaluate the Safety and Effectiveness of the BioBrace® Implant during Arthroscopic Repair of Full Thickness Rotator Cuff Tears

Brief description:

Failure of surgical repair of rotator cuff tendon injury is primarily attributed to the tearing of sutures through the tendon due to tensile stress near the site of attachment of the tendon and bone. To address this failure, biologic and synthetic products, such as the BioBrace Implant have been developed with the goals of strengthening the mechanical integrity of the repair and increasing the healing potential of native tissues. The BioBrace implant is a bioresorbable, biocomposite scaffold composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen and reinforced with poly-L-lactic acid (PLLA) multifilament yarn.

Sponsor: CONMED