Tendon tears or tissue failures after rotator cuff repair are reported to occur for some age groups in as many as 60%. In an effort to avoid retears, augmentation of the deficient rotator cuff repair with the incorporation of a biologic tissue scaffold has been advocated. The purpose of this study was to prospectively evaluate the effectiveness of arthroscopic acellular human dermal matrix augmentation on rotator cuff repair and to determine whether rotator cuff repair augmentation differs with respect to safety, when compared to standard suture and anchor repair.
47 patients were prospectively randomized by means of sealed envelopes opened at the time of surgery to rotator cuff repair with acellular human dermal matrix augmentation (Group I) or repair without augmentation (Group II). In addition, each participating investigator in this multicenter study performed the rotator cuff repairs exclusively by an arthroscopic approach throughout the entire enrolment period. Preoperative and postoperative functional outcome assessments were obtained using the Constant-Murley and American Shoulder and Elbow Surgeons (ASES) scales. MRI evaluation of these repairs was also obtained at 12 months. Patients were followed for a minimum 12 months after surgery. Adverse events were recorded.
There were 24 patients in Group I and 23 in Group II with a mean age of 56 years. 33 were male and 14 female. 32 had acute cuff tears and 15 chronic tears. The Constant-Murley scores were 89.6 (SD 9.4) for Group I and 85.7 (SD 9.9) for Group II. ASES scores were 95.1 (SD 4.8) for Group I and 93.2 (SD 7.9) for Group II. There were no significant differences between the two groups for either the Constant-Murley scores or the ASES scores. One retear was documented by MRI in each group. Adverse events in Group I included recurrent shoulder bursitis and one rotator cuff retear. Group II adverse events included cellulitis in 2, shoulder bursitis, post-traumatic fibrosis, one rotator cuff retear, and a biceps tendon rupture. No adverse events were attributed to the presence of the matrix grafts.
No differences in Constant-Murley, ASES scores, or MRI demonstrated cuff retears were observed at a minimum of 12 months follow-up. Adverse events were more common in the control group than the augmented rotator cuff repairs.
© 2010 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.