Treatment of Partial-Thickness Rotator Cuff Repairs With A Resorbable Bioinductive Bovine Collagen Implant: 1-Year Results From A Prospective Multi-Center Registry

Abstract

Objectives: Surgical treatment of partial-thickness rotator cuff tears remains challenging and controversial, with several traditional options including debridement with acromioplasty, transtendon or in-situ repair, and take-down and repair. A bioinductive resorbable bovine collagen implant has shown promise as an alternative treatment option for partial-thickness tears. It was our hypothesis that data from a comprehensive, prospective, multi-center registry will further establish the implant’s efficacy and safety across larger numbers of patients. Methods: Nineteen US centers enrolled patients >21 years old with partial-thickness tears of the rotator cuff. Patient-reported outcome (PRO) scores including the American Shoulder and Elbow Surgeons (ASES), single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12) for both Physical Component Score (PCS) and Mental Component Score (MCS), and Western Ontario Rotator Cuff (WORC) outcome measures were recorded at pre-operative baseline, surgery, and postoperatively at 2 and 6 weeks, 3 and 6 months, and 1 year. Revisions were reported throughout the study. Results: The registry included 272 patients with partial-thickness tears (49 grade 1 tears, 101 grade 2 tears, and 122 grade 3 tears), 241 who underwent isolated bioinductive repair (“IBR”; collagen implant placed over the tear following bursectomy without a traditional rotator cuff repair - FIGURE 1) and 31 tradtitional take-down and repair with supplemental placement of the implant. Patients experienced statistically significant and sustained improvement from baseline for all PRO scores beginning at 3 months (TABLE 1). Among patients with grade ≥2 tears, those with take-down and repair had significantly inferior scores at 2 and 6 weeks for most PRO scores compared with those undergoing IBR, but the difference was no longer significant at 1 year for all but VR-12 PCS. There were 11 revisions, which occurred at a mean of 188.7 days (standard deviation, 88.0) after index surgery. Conclusions: Efficacy and safety of the implant are further established across a larger data set. IBR may offer improved early clinical outcomes and equivalent long-term results to supplemented take-down and repair, potentially with lower risk of complications. This implant can improve rotator cuff healing and clinical outcomes with minimal revisions. [Table: see text]