Safety and efficacy evaluation of a human acellular nerve graft as a digital nerve scaffold: a prospective, multicentre controlled clinical trial

Abstract

This study developed a human acellular nerve graft (hANG) as an alternative to autogenous nerve and reports on its safety and efficacy. There were two groups comprised of 72 patients that received digital nerve repair with hANG (test) and 81 that received conventional direct tension-free suture repair of the nerve defect (control). The efficacy of the treatment was evaluated by static 2-point discrimination (s2PD) and Semmes-Weinstein monofilament testing. Safety was evaluated by local wound response and laboratory testing. Mean age of patients in the test group was 33.0 ± 11.1 years (range 18-61 years) and in the control group 36.9 ± 13.4 years (range 15-77 years) (p = 0.0470). Mean time from injury to repair in the test group was 23.7 ± 52 days (range 0-200 days) and in the control group 1.5 ± 10.4 days (range 0-91 days) (p = 0.0005). Mean length of nerve graft was 1.80 ± 0.82 cm (range 1-5 cm). All surgeries were performed successfully and without complications. The excellent and good rate of s2PD in the test group was 65.28% and 95% CI was 51.98-78.93%. s2PD in the test group improved over time and average distance was 12.81 ± 5.99 mm at 6 months postoperatively. No serious adverse or product-related events were reported. These results indicate that hANG is a safe and effective for the repair of nerve defects of 1-5 cm in size.