REPAIR OF MASSIVE ROTATOR CUFF TEARS REINFORCED BY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT. PRELIMINARY STUDY

Introduction: In many cases of massive rotator cuff tears, especially in cases of revision repairs the shoulder surgeon is facing a technical and biological challenge. The loss of collagenous material in the tendon, coupled with poor quality of the remaining rotator cuff, makes obtaining a mechanically strong repair difficult. Primary closure of such defects may result in excessive tissue tension, which may further increase the chance of failure. Purpose: The objective of this study is to determine the feasibility of using xenogeneic small intestine submucosa (SIS) as a biomaterial to reinforce repair of massive rotator cuff tears. Clinical Material and Methods: Nine patients ranging in age from 52 to 74 with massive rotator cuff tears were selected for the study. Selection of these patients was based upon the quality of remaining rotator cuff tendon tissue at the time of the repair. Seven cases after failed repair of massive rotator cuff tear and two cases of long standing neglected rotator cuff tears in patients with weight bearing shoulders (bilateral below the knees amputation and incomplete paraplegia after anterior poliomyelitis) were selected for this study. In all patients first the tear was repaired by well-known techniques: tendon to tendon, tendon to bone through bone tunnels or using suture anchors. After the repair was accomplished, the poor quality tissue obtained was reinforced by a patch of Restore Orthobiologic Soft Tissue Implant (DePuy, Johnson & Johnson). The Restore Implant is a xenograft obtained of ten layers of porcine small intestine submucosa, it is biocompatible, infection resistant, possess predictable mechanical properties, and, perhaps most significantly, induce a host connective and epithelial tissue response that results in regeneration of specialized connective tissues. Results: Follow-up ranging between 6 to 22 month excellent and good results were observed in eight cases (88%), whereas in the patient aged 74, the cuff repair failed again (after two previous failures). In the eight successful cases an almost normal painfree active range of movements was observed three month after surgery. Conclusions: The results confirm the usefulness of the SIS graft material in the patients having questionable quality cuff tissue remaining after repair. Use of the Restore soft tissue implant could possibly be utilized to strengthen the repair, as well as the inside ingrowth of the tendon, leading to a successful repair of the rotator cuff.