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Porcine Small Intestine Submucosa Augmentation of Surgical Repair of Chronic Two-Tendon Rotator Cuff Tears

A Randomized, Controlled Trial

¹ Department of Orthopaedic Surgery A-41, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195. E-mail address for J.P. Iannotti: iannotj{at}ccf.org
² Hospital for Joint Diseases, 301 East 17th Street, New York, NY 10003

Investigation performed at the Department of Orthopaedic Surgery and the Orthopaedic Research Center, Cleveland Clinic Foundation, Cleveland, Ohio

In support of their research for or preparation of this manuscript, one or more of the authors received National Institutes of Health Grant 1T32 AR050959-01. In addition, one or more of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity (DePuy Johnson and Johnson). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Methods: Thirty shoulders with a chronic two-tendon rotator cuff tear that was completely repairable with open surgery were randomized to be treated with either augmentation with porcine small intestine mucosa or no augmentation. All patients completed a PENN shoulder-score questionnaire preoperatively and at the time of the latest follow-up (at an average of fourteen months). Magnetic resonance imaging showed that nine shoulders had a large tear and twenty-one had a massive tear. All patients underwent a magnetic resonance imaging scan with intra-articular gadolinium one year after the repair to assess the status of the rotator cuff.

Results: The rotator cuff healed in four of the fifteen shoulders in the augmentation group compared with nine of the fifteen in the control group (p = 0.11). The median postoperative PENN total score was 83 points in the augmentation group compared with 91 points in the control group (p = 0.07). Healing of the defects in both groups demonstrated a strong correlation with the patients' clinical scores. The median postoperative PENN total score was 96 points in the group with a healed repair and 81 points in the group with a failed repair (p = 0.007). The percentage change between the preoperative and postoperative patient satisfaction scores was 400% in the group with a healed repair, and 50% in the group with a failed repair (p = 0.04).

Conclusions: Augmentation of the surgical repair of large and massive chronic rotator cuff tears with porcine small intestine submucosa did not improve the rate of tendon-healing or the clinical outcome scores. On the basis of these data, we do not recommend using porcine small intestine submucosa to augment repairs of massive chronic rotator cuff tears done with the surgical and postoperative procedures described in this study.

Level of Evidence: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

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