Two-year outcomes with a bioinductive collagen implant used in augmentation of arthroscopic repair of full-thickness rotator cuff tears: final results of a prospective multicenter study

Abstract

Background: Full-thickness rotator cuff tears (FTRCTs) represent a common shoulder injury that, if untreated, can progress in size, become increasingly painful, and inhibit function. These lesions are often surgically repaired, with double-row arthroscopic repair often preferred for larger tears. Biological augmentation technologies have been developed to improve rates of postoperative radiographic retear and enhance patient-reported outcomes after surgical FTRCT repair. This study sought to confirm that augmented repair with a bioinductive bovine collagen implant results in favorable retear rates and patient outcomes with follow-up to 2 years.

Methods: A prospective multicenter cohort study was undertaken to determine the efficacy and safety of augmenting single- or double-row arthroscopic repair of FTRCTs with a bioinductive bovine collagen implant. Of 115 adult patients participating, 66 (57.4%) had medium (1-3-cm) tears and 49 (42.6%) had large (3-5-cm) tears. Magnetic resonance imaging and patient-reported outcomes (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form [ASES] and Constant-Murley Score [CMS]) were performed and recorded at baseline, 3 months, 1 year, and 2 years.

Results: Mean duration of follow-up was 2.1 years (range, 1.5-2.9 years). Between baseline and 2-year follow-up, mean total thickness of the supraspinatus tendon increased by 12.5% for medium tears and by 17.1% for large tears. Radiographic retear was noted in 7 of 61 available patients (11.5%) with medium tears, and in 14 of 40 patients (35.0%) with large tears. In both groups, these tears primarily occurred before the 3-month follow-up visit (13 of 21 [61.9%]). Radiographic retear with the supplemented double-row (DR) repair technique was 13.2% overall (12 of 91 DR patients; 11.3% for medium tears and 15.8% for large tears). The minimal clinically important difference was achieved by >90% of patients with both medium and large tears for both ASES and CMS. There were 2 serious adverse events classified by the treating surgeon as being possibly related to the device and/or procedure (1 case of swelling/drainage and 1 case of intermittent pain). Nine patients (7.8%; 4 medium tears and 5 large tears) required reoperation of the index rotator cuff surgery.

Conclusion: Final 2-year data from this study confirm that using this implant in augmentation of arthroscopic double-row repair of FTRCTs provides favorable rates of radiographic retear and substantial functional recovery. The relative safety of the device is also further supported.

Keywords: ASES; CMS; Rotator cuff; bioinductive; clinical outcomes; full-thickness; implant; retears.