Effect of Porcine-Derived Absorbable Patch-Type Atelocollagen for Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial

Abstract

Background: Even though arthroscopic rotator cuff repair is recognized as a standard treatment option, the risk of postoperative retear is a major concern. Purpose: To evaluate the effect of porcine-derived absorbable patch-type atelocollagen during arthroscopic rotator cuff repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 64 patients with rotator cuff tears diagnosed on magnetic resonance imaging (MRI) were enrolled prospectively from November 2020 to December 2021. Both groups had repairs using the suture bridge technique. For the atelocollagen group, before securing the lateral anchors, we inserted porcine-derived absorbable patch-type atelocollagen between the footprint and the tendon. On postoperative day 2, the patients underwent MRI to confirm containment of the patch-type atelocollagen. At 6 months and 1 year postoperatively, the signal intensity of the repaired tendon was assessed using MRI. Patients were evaluated using the Constant score as the primary outcome, along with the visual analog scale for pain; range of motion; American Shoulder and Elbow Surgeons score; University of California, Los Angeles, score; and Korean Shoulder Score preoperatively and at 2, 3, 6, and 12 months postoperatively. Results: No significant changes in the Constant score as primary outcome, pain or other functional scores, and range of motion were observed between the groups at 1 year postoperatively. The patch-type atelocollagen was confirmed to be contained by the time-zero MRI scan taken 2 days postoperatively. Among the 55 patients included in final analysis, 12 retear cases were recorded (21.8% retear rate). A significantly lower retear rate was found in the atelocollagen group, as 3 cases were observed in this group (10.3%) and 9 cases were observed in the conventional repair group (34.6%) (P = .048). Conclusion: The Constant score was not different between the groups. The retear rate after rotator cuff repair was significantly lower in the group that received porcine-derived absorbable patch-type atelocollagen compared with in the conventional group. Registration: KCT0005184 (Clinical Research Information Service [CRIS]; https://cris.nih.go.kr).