A prospective, multicenter study to evaluate clinical and radiographic outcomes in primary rotator cuff repair reinforced with a xenograft dermal matrix

Abstract

Background: Minimal information is currently available on the outcome of rotator cuff repair reinforced with an extracellular matrix (ECM) graft. Therefore, the purpose of this study was to determine the clinical and radiographic outcome of repair of large rotator cuff tears with ECM graft reinforcement.

Methods: This was a prospective study of 61 shoulders with large repairable rotator cuff tears (3 to 5 cm). The rotator cuff tears were surgically repaired and reinforced with a xenograft ECM graft. The average patient age was 56 years (range, 40-69 years). The average tear size was 3.8 cm.

Results: Follow-up was obtained at 6, 12, and 24 months in 58, 54, and 50 of the 61 patients, respectively. Functional outcome scores, isometric muscle strength, and active range of motion were significantly improved compared with baseline. Magnetic resonance imaging at 12 months showed retorn rotator cuff repairs in 33.9% of shoulders, using the criteria of a tear of at least 1 cm, and tears in 14.5% of the shoulders using the criteria of retear >80% of the original tear size. Three patients underwent surgical revision. Complications included 1 deep infection.

Conclusions: Repair of large rotator cuff tears structurally reinforced with xenograft ECM resulted in improved functional outcomes scores and strength. Adverse events were uncommon, and the rate of revision surgery was low.

Keywords: Prospective; augmentation; extracellular matrix; repair; rotator cuff; xenograft.