Clinical outcomes and ultrasonographic viability of GraftJacket® augmented rotator cuff repair: a prospective follow-up study with mean follow-up of forty-one months

Background: The management of large rotator cuff tears in patients without evidence of glenohumeral arthritis is challenging and controversial. We wished to investigate the viability of Graft Jacket® augmentation and assess the clinical and radiological outcomes in a prospective study with a select cohort of patients.

Methods: All procedures were performed by a single shoulder surgeon over a three-year period. Inclusion criteria were patients with large cuff tears (size 3–5 cm) not amenable to end-to-end repair. Patients with radiographic evidence of glenohumeral arthritis or cuff tear arthropathy were excluded. Open rotator cuff repair followed by bridging with GraftJacket® Regenerative Tissue Matrix was performed. Outcome was assessed with Constant scores (CS), QuickDash (QD) and Oxford Shoulder scores (OSS) at minimum twenty-two months and ultrasound assessment at nine months post-operatively.

Results: Thirteen patients were identified who fit inclusion criteria (one bilateral). No patients were lost to follow up. At final follow-up thirteen shoulders had achieved function range of movement. Mean CS was 83 (range 70–100), mean Quick DASH was 5.4 (range 0–18.2), and mean OSS was 46 (range 41–48). Shoulder ultrasound revealed an intact Graft Jacket® in these patients. One patient had lower functional movement and worse CS (34), QD (34.1) and OSS (25) and ultrasound assessment identified a re-rupture.

Discussion: This study indicates that augmentation of large rotator cuff repairs with a GraftJacket® scaffold is a viable option and has good functional results and sustained viability. Level of evidence: Level 4.