Evaluation of safety and efficacy of a resorbable collagen IMplant in treatment of High Grade PArtial ThiCkness Tears (IMPACT)

Brief description:

IMPACT is a prospective, multicent

er, randomized control trial that aims to evaluate the functional recovery of patients with high grade partial thickness tears when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR). Long term clinical and imaging outcomes will also be evaluated to determine the effectiveness of IBR. The Bioninductive Implant, provided by Smith+Nephew, is used for the IBR. The implant itself is comprised of a resorbable bovine collagen scaffold, poly-l/d-lactide (PLDLA) anchors to secure the scaffold to the underlying tendon, PEEK anchors to secure the implant to bone, and disposable instruments.

Sponsor: Smith+Nephew