Evaluating the Use of a Bioinductive Graft in Treating Massive Rotator Cuff Tears

Summary

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Description

Rotator cuff injuries are among the most common soft tissue injuries of the shoulder. Characterized by insidious onset of progressive pain and weakness, with concomitant loss of range of motion, patients with pathological conditions of the rotator cuff are often unable to associate the onset of symp...

Rotator cuff injuries are among the most common soft tissue injuries of the shoulder. Characterized by insidious onset of progressive pain and weakness, with concomitant loss of range of motion, patients with pathological conditions of the rotator cuff are often unable to associate the onset of symptoms with a specific traumatic event. Loss of continuity of the rotator cuff can be described in several ways, including acute or chronic, partial or full-thickness and traumatic or degenerative. For this study, only patients with radiography confirmed large rotator cuff tears (> 3 cm) resulting from trauma and/or degeneration will be observed. Historically, many operative procedures have been used by surgeons in the treatment of large rotator cuff tears including open rotator cuff repair, mini- open rotator cuff repair, arthroscopic rotator cuff repair, bridging techniques, debridement, arthroscopic rotator cuff repair with acromioplasty, arthroscopic rotator cuff repair without acromioplasty, surgical augmentation, debridement etc. While the surgical repair of large rotator cuff tears has resulted in pain relief and improved function, the re-tear rate (55%-94%) has remained high despite advances in repair techniques. The re-tear rates correlate with the size of the rotator cuff tear as well as with other factors such as muscle atrophy, tendon quality, and postoperative rehabilitation protocol. With an effort to improve healing rates, surgeons have used various biologic tissues to either substitute for or augment the repair of the rotator cuff. These tissues include the patients' biceps tendon, fascia latae allografts and autografts, freeze-dried rotator cuff allografts, and synthetic materials such as polypropylene mesh.1 A new scaffold material made of highly purified, type I collagen from bovine tendons has shown great promise as a bioinductive implant that helps induce the formation of new tendon-like tissue over the surface of partial- or full-thickness rotator cuff tears.This new graft material has the benefit of decreasing surgery time, as it takes a few minutes to put in place, while increasing healing and tendon thickness. The investigators hypothesize that arthroscopic augmentation using a bioinductive collagen implant will have superior outcomes in terms of increasing healing, thereby decreasing re-tear rate, as compared to participants who are treated with the current gold standard treatment (consisting of debridement, acromioplasty, and rotator cuff repair). The investigators hypothesize that the participants with graft augment will have decreased pain both during the early recovery phase and two years post-operatively as compared to the non-augmented group. Additionally, the investigators hypothesize that participants with the collagen scaffold will have better outcome scores at two years, as compared to the non-augmented group.

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