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Multicenter Observational Study of 215 Nerve Repairs with Processed Nerve Allograft
Bauback Safa, M.D., Gregory M. Buncke, MD.
The Buncke Clinic, San Francisco, CA, USA.

Purpose
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 understanding of their expanded clinical utilization and 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 18 centers with 36 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 62% to result in a database of 157 subjects with 215 repairs. Repairs reporting sufficient follow-up data for outcomes analysis increased by 38% to 105 injuries with quantitative data available in 83 repairs (60 sensory, 7 motor, 16 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±2.7mm (n=39). 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 continues to enroll, tracking additional utilization and outcomes data to support an evidence-based data approach in peripheral nerve repairs.


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