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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.

SUBMITTER: Safa B

PROVIDER: S-EPMC7496926 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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

Safa Bauback B Jain Sonu S Desai Mihir J MJ Greenberg Jeffrey A JA Niacaris Timothy R TR Nydick Jason A JA Leversedge Fraser J FJ Megee David M DM Zoldos Jozef J Rinker Brian D BD McKee Desirae M DM MacKay Brendan J BJ Ingari John V JV Nesti Leon J LJ Cho Mickey M Valerio Ian Lee IL Kao Dennis S DS El-Sheikh Yasser Y Weber Renata V RV Shores Jaimie T JT Styron Joseph F JF Thayer Wesley P WP Przylecki Wojciech H WH Hoyen Harry A HA Buncke Gregory M GM

Microsurgery 20200226 5

<h4>Background</h4>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.<h4>Methods</h4>This multicenter IRB-approved registry study collected data from patients repaired with proc ...[more]

PMID: 32101338

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Project description:Current repair options for peripheral nerve injuries where tension-free gap closure is not possible include allograft, processed nerve allograft, and hollow tube conduit. Here we report on the outcomes from a multicenter prospective, randomized, patient- and evaluator-blinded, pilot study comparing processed nerve allograft and hollow conduit for digital nerve reconstructions in the hand.Across 4 centers, consented participants meeting inclusion criteria while not meeting exclusion criteria were randomized intraoperatively to either processed nerve allograft or hollow conduit. Standard sensory and safety assessments were conducted at baseline, 1, 3, 6, 9, and 12 months after reconstruction. The primary outcome was static 2-point discrimination (s2PD) testing. Participants and assessors were blinded to treatment. The contralateral digit served as the control.We randomized 23 participants with 31 digital nerve injuries. Sixteen participants with 20 repairs had at least 6 months of follow-up while 12-month follow-up was available for 15 repairs. There were no significant differences in participant and baseline characteristics between treatment groups. The predominant nerve injury was laceration/sharp transection. The mean ± SD length of the nerve gap prior to repair was 12 ± 4 mm (5-20 mm) for both groups. The average s2PD for processed allograft was 5 ± 1 mm (n = 6) compared with 8 ± 5 mm (n = 9) for hollow conduits. The average moving 2PD for processed allograft was 5 ± 1 mm compared with 7 ± 5 mm for hollow conduits. All injuries randomized to processed nerve allograft returned some degree of s2PD as compared with 75% of the repairs in the conduit group. Two hollow conduits and one allograft were lost due to infection during the study.In this pilot study, patients whose digital nerve reconstructions were performed with processed nerve allografts had significantly improved and more consistent functional sensory outcomes compared with hollow conduits.

Dataset Information

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

Publications

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

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