Ultrasound and patient-reported outcomes of rotator cuff repair with new acellular human allograft at 6 months and 1 year post surgery

Abstract

PurposeDetermine the effect of a novel acellular cannulated dermal allograft, on tendon-to-bone healing, retear rates, and clinical outcomes over a 12-month period. MethodsThis was a single surgeon prospective non-randomized case series. Patients with medium sized full-thickness superior and posterosuperior rotator cuff tears, as confirmed by magnetic resonance imaging (MRI), were consented. Patients were excluded if they had fatty atrophy indicative of Goutallier grade III or IV. The allograft is a cannulated rectangular prism that has a 5-year shelf life, does not require prehydration, and does not need to be trimmed to size. Outcome metrics included ultrasound (US) assessment at 1 year as well as 6 month patient reported outcomes scores. Results31 patients consented and enrolled in this consecutive cohort series. 9 patients were excluded and statistical analysis was performed on the remaining 22 patients. There were 9 females and 13 males. The average age was 59.27 ± 7.48 years old. The average supraspinatus short axis measurement in males was 0.56 ± 0.12 cm and 0.52 ± 0.09 cm in females (p=0.44). The average supraspinatus long axis measurement in males was 0.61 ± 0.18 cm and 0.55 ± 0.14 cm in females (p=0.46). The average infraspinatus short axis measurement in males was 0.48 ± 0.10 cm and 0.50 ± 0.13 in females (p=0.74). The average infraspinatus long axis measurement in males was 0.44 ± 0.12 cm and 0.43 ± 0.08 cm in females (p=0.84). Of the 19 patients who completed baseline and 6 month PRO’s, 17 achieved the MCID for ASES and PROMIS UE 7a. Retear occurred in 2 cases. The remaining 20 cases have all demonstrated healing or fully healed repairs at their most recent clinic visits with no additional cases of retears. ConclusionThis study is the first to report the results of a novel acellular dermal allograft for Rotator Cuff Repair Augmentation. Satisfactory patient-reported outcome measures and robust tendon healing at 1 year as measured by ultrasound demonstrate the utility of a cannulated human acellular dermal allograft as a viable biologic augmentation device for Rotator Cuff repair.