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Outcomes from an Expanded National Registry Study on Sensory, Mixed, and Motor Nerve Injuries Repaired with Processed Nerve Allograft
Bauback Safa, MD1; Mickey Cho, MD2; Wesley Thayer, MD, PhD3; Brian Rinker, MD4; Ingari V John, MD5; Jozef Zoldos, MD6; Timothy R Niacaris, MD, PhD7; Peter Evans, MD, PhD8; Harry Hoyen, MD9; Gregory M. Buncke, MD1
1The Buncke Clinic, San Francisco, CA, 2San Antonio Military Medical Center, San Antonio, TX, 3Vanderbilt University, Nashville, TN, 4University of Kentucky, Lexington, KY, 5Johns Hopkins Medicine, Baltimore, MD, 6Arizona Center for Hand Surgery, Phoenix, AZ, 7UNT Health Science Center, Fort Worth, TX, 8Cleveland Clinic, Cleveland, OH, 9MetroHealth System, Cleveland, OH
Introduction: Processed nerve allografts (PNA) have been shown to be safe and effective option to repair nerve gap injuries in a growing number of clinical studies. The RANGER registry, initialed in 2007, is an active database designed to collect utilization and outcomes data for processed nerve allografts (Avance® Nerve Graft, AxoGen) used to repair sensory, mixed, and motor nerves in all regions of the body. In 2013, internal registry controls for nerve autograft and nerve conduit added. Initial reports of cumulative registry outcome were first published in 2010. Here we provide an update on the recovery outcomes on nerves repaired using processed nerve allografts.
Methods: The RANGER database was queried for peripheral nerve repairs using PNA that reported sufficient quantitative outcomes. The cohort was further stratified into nerve type and mechanism of injury subgroups. Reported sensory and/or motor assessments included 2-point discrimination, Semmes-Weinstein Monofilament (SWMF) testing, range of motion, strength test. Reported outcome data were incorporated into the MRCC scale for sensory and motor function. Meaningful recovery was defined as ≥S3/M3 on the MRCC scale.
Results: The current RANGER® registry has sufficient quantitative outcomes data on 250 repairs (207 sensory, 32 mixed and 11 motor nerve injuries). Mean age of the cohort was 43 ±17 (18–81) years. Mean gap length was 22 ±12 (3–65) mm with a mean follow up time of 338 ±214 days. Meaningful recovery was observed in 84% of all repairs. Among repairs with more than 9 months follow-up, 63% reported higher threshold recovery with S3+/M4 or greater. Analysis by nerve type observed recovery in 86% of sensory, 75% of mixed and 70% of motor repairs. See Table 1. No adverse events were reported. Outcomes were comparable to internal registry controls for nerve autograft and exceed those for nerve conduit with 71% and 51% recovery respectively.
Conclusion: Outcomes from the expanded registry provided additional evidence that processed nerve allografts continue to be a safe and reliable off-the-shelf alternative for the reconstruction of nerve deficits. Quantitative data demonstrate meaningful recovery in 84% of all repairs, 86% of sensory, 75% of mixed and 70% of motor nerve repairs. These results compare favorably to historical and internal control outcomes for autografts and exceed those for conduits. The registry remains ongoing and will continue to expand to further collect outcomes data on processed nerve allografts.
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