Peripheral nerve repair throughout the body with processed nerve allografts: Results from a large multicenter study

Abstract

Background Peripheral nerve damage resulting in pain, loss of sensation, or motor function may necessitate a reconstruction with a bridging material. The RANGER® Registry was designed to evaluate outcomes following nerve repair with processed nerve allograft (Avance® Nerve Graft; Axogen; Alachua, FL). Here we report on the results from the largest peripheral nerve registry to‐date. Methods This multicenter IRB‐approved registry study collected data from patients repaired with processed nerve allograft (PNA). Sites followed their own standard of care for patient treatment and follow‐up. Data were assessed for meaningful recovery, defined as ≥S3/M3 to remain consistent with previously published results, and comparisons were made to reference literature. Results The study included 385 subjects and 624 nerve repairs. Overall, 82% meaningful recovery (MR) was achieved across sensory, mixed, and motor nerve repairs up to gaps of 70 mm. No related adverse events were reported. There were no significant differences in MR across the nerve type, age, time‐to‐repair, and smoking status subgroups in the upper extremity ( p > .05). Significant differences were noted by the mechanism of injury subgroups between complex injures (74%) as compared to lacerations (85%) or neuroma resections (94%) ( p = .03) and by gap length between the <15 mm and 50–70 mm gap subgroups, 91 and 69% MR, respectively ( p = .01). Results were comparable to historical literature for nerve autograft and exceed that of conduit. Conclusions These findings provide clinical evidence to support the continued use of PNA up to 70 mm in sensory, mixed and motor nerve repair throughout the body and across a broad patient population.

Reconstruction of Critical Nerve Defects Using Allogenic Nerve Tissue: A Review of Current Approaches

“…In 2020 Safa et al [ 64 ], and Leckenby et al [ 65 ] released the latest data from the RANGER study. Safa et al, 2020 [ 64 ] analyzed 624 nerve repairs in 385 subjects. Nerve gap length variated by 1.5–7.0 cm.…”

“…Clinical results following Axogen Avance ® engraftment are encouraging. Most reviewed studies were able to achieve a meaningful recovery in upper 8th percentile of all cases [ 55 , 57 , 58 , 60 , 62 , 63 , 64 ]. Satisfactory motor recovery was reported in 40.1% to 74%.…”

Effects of Chemical and Radiation Sterilisation on the Biological and Biomechanical Properties of Decellularised Porcine Peripheral Nerves

“…Currently, two decellularised human nerve grafts have undergone multicentre clinical evaluations; a non-commercial nerve graft for sensory nerve defects in China ( He et al, 2015 ) and the commercial Avance ® nerve graft from Axogen in the United States ( Kasper et al, 2020 ; Safa et al, 2020 ). Both are sterilised with 25 kGy gamma radiation; however, it is unclear why this method was selected, and limited data are available regarding the effects of the sterilisation process in isolation on the properties of the decellularised nerve tissue.…”

Nerve Grafting in Head and Neck Reconstruction

“…Several large multicenter studies have demonstrated the efficacy of PNA in peripheral nerve repair throughout the body. 1,18 Most recently, Safa et al reported 624 repairs of peripheral nerve injuries, with an overall meaningful recovery of 82% of patients across sensory, mixed, and motor nerves with gaps up to 70 mm. 18 The vast majority of these repairs were upper and lower extremity, with relatively few head and neck repairs included; however, within the head and neck data, all sensory and motor repairs reported meaningful recovery.…”