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

Abstract

Background

Determine the effect of a novel acellular cannulated dermal allograft on tendon-to-bone healing, retear rates, and clinical outcomes over a 12-month period.

Methods

This was a single surgeon prospective nonrandomized case series. Patients with medium sized full-thickness superior and posterosuperior rotator cuff tears, as confirmed by magnetic resonance imaging, 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 assessment at 1-year as well as 6-month patient-reported outcomes (PROs) scores.

Results

31 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 year old. The average supraspinatus short axis measurement in males was 0.56 ± 0.12 cm and 0.52 ± 0.09 cm in females (P = .44). The average supraspinatus long axis measurement in males was 0.61 ± 0.18 cm and 0.55 ± 0.14 cm in females (P = .46). The average infraspinatus short axis measurement in males was 0.48 ± 0.10 cm and 0.50 ± 0.13 in females (P = .74). The average infraspinatus long axis measurement in males was 0.44 ± 0.12 cm and 0.43 ± 0.08 cm in females (P = .84). Of the 19 patients who completed baseline and 6-month PRO’s, 17 achieved the minimal clinical important difference for American Shoulder and Elbow Surgeons and Patient-Reported Outcomes Measurement Information SystemUE 7a. Retear occurred in 2 cases. The remaining 20 cases have all demonstrated healing or fully healed repairs at their most recent clinical visits with no additional cases of retears.

Conclusion

This study is the first to report the results of a novel acellular dermal allograft for rotator cuff repair augmentation. Satisfactory PRO 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.