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The Second Data Milestone of an Expanded Enrollment from an Ongoing Multicenter Registry Study on the Use of Processed Nerve Allograft for Sensory, Mixed, and Motor Nerve Reconstructions
Bauback Safa, MD1; Brian Parrett, MD1; Jozef Zoldos, MD2; John Ingari, MD3; Wesley Thayer, MD, PhD4; Brian Rinker, MD5; Darrell Brooks, MD1; Gregory M. Buncke, MD1; (1)The Buncke Clinic, (2)Arizona Center for Hand Surgery, (3)WellSpan Health Orthopedics, (4)Vanderbilt University, (5)University of Kentucky
The Buncke Clinic, San Francisco, CA, USA

Introduction

In 2008, a multicenter registry was initiated to capture data on the use of processed nerve allografts (Avance® Nerve Graft, AxoGen, Inc.). As the utilization of these grafts has been incorporated into standard treatment algorithms, we seek to provide additional clinical data on their expected outcomes. Here we report our findings from the second data milestone from this ongoing registry (RANGER) on the safety and efficacy of processed nerve allograft in today’s clinical practice.

Methods

The RANGER registry, established in 16 centers with 32 surgeons, is designed to continuously monitor and incorporate injury, repair, safety and outcomes data using standardized case report forms entered into a centralized database. Centers followed their own standard of care for treatment and follow-up. Outcome measures were reviewed and reported. A secondary review and analysis was completed. Meaningful recovery was defined by the MRCC scale at S3-S4 for sensory and M3-M5 for motor.

Results

Upon completion of the first data milestone, additional subjects and follow-up were incorporated increasing available data by 42% to result in a database of 143 subjects with 188 repairs. Repairs reporting sufficient follow-up data for outcomes analysis increased by 26% to 96 injuries with quantitative data available in 74 repairs (52 sensory, 7 motor, 15 mixed). The mean ±SD (minimum, maximum) age was 41±15 (18-70). The mean gap was 23±12 (5-50) mm. Quantitative outcomes data reported meaningful recovery in 89.7% of the repairs. Outcomes were further stratified for additional subgroup analysis. See Table 1. The average s2PD was 7.9±2.5mm (n=35). Return to light touch or greater was demonstrated in 25 of 34 repairs reporting SWMF scores. NCS completed in 5 repairs reported reinnervation into target endpoints. No graft related adverse experiences were reported.

Conclusions

Comparisons of the 1st and 2nd data milestone continue to demonstrate that Avance® Nerve Graft is safe and effective in sensory, motor, and mixed nerve defects between 5 and 50mm. These outcomes compare favorable to historical data in the literature for nerve repair with Autograft and exceed that for Conduit. This study is currently in open enrollment; additional data incorporated into the registry will allow for continued analysis on the role of processed nerve allografts in the treatment algorithms for peripheral nerve injuries.


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