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Evaluating Nerve Repair Outcomes after 105 Nerve Reconstructions in the Upper Extremity Utilizing Processed Nerve Allografts

Bauback Safa, M.D.1, Brian Parrett, MD1, Renata V. Weber, MD2, Jozef Zoldos, MD3, Brian D. Rinker, MD4, Wesley P. Thayer, MD5, John V. Ingari, MD6, Mickey S. Cho, MD7, Jeffrey A. Greenberg, MD8, Darrell Brooks, MD9, Gregory M. Buncke, MD1.
1The Buncke Clinic, San Francisco, CA, USA, 2Institute for Nerve, Hand and Reconstructive Surgery, Rutherford, NJ, USA, 3Arizona Center for Hand Surgery, Phoenix, AZ, USA, 4University of Kentucky, Lexington, KY, USA, 5Vanderbilt University, Nashville, TN, USA, 6WellSpan Orthopedics, York, PA, USA, 7San Antonio Military Medical Center, Fort Sam Houston, TX, USA, 8Indiana Hand to Shoulder Center, Indianapolis, IN, USA, 9California Pacific Medical Center, 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 clinical data on their expected outcomes. The registry database was analyzed and subgroup analysis was performed on a subset of subjects with complex nerve reconstructions. These were defined as traumatic nerve injuries requiring extensive resection of damaged nerve tissue and/or debridement and repair of the surrounding wound bed. Here we report our findings from this ongoing registry (RANGER) of these injuries reconstructed using processed nerves allografts.
Methods:
The RANGER registry, established in 18 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. The database reported 81 subjects with 105 nerve repairs reporting quantitative outcomes; 55 of these repairs were identified as complex nerve reconstructions. Outcome measures were reviewed and subgroup analysis was completed. Meaningful recovery was defined by the MRCC scale at S3-S4 for sensory and M3-M5 for motor.
Results:
The mean ± SD (minimum, maximum) age was 42 ± 16 (18, 77). The mean gap length was 22 ± 10 (8, 50) mm and the time-to-repair (TTR) was 121 ± 276 (0,949), with median TTR of 4 days. Mechanisms of injury included: 29 saw injuries, 7 chronic neuromas, 5 crush/compression injuries, 4 amputations, 4 avulsions, 3 blast, and 3 gunshot injuries. Forty six were sensory repairs in the hand and 9 were mixed nerve repairs in the forearm. Quantitative data demonstrate meaningful recovery in 82% of these cases. See Fig 1 for outcomes by MRCC sensory and motor scores. There were no reported adverse events related to the nerve graft.
Conclusion:
We found that when used in conjunction with aggressive debridement and standard repair techniques, processed nerve allografts performed well when utilized in complex nerve reconstructions in the upper extremity. Quantitative data demonstrate meaningful recovery in 82% of these cases. This compares favorably to the outcomes for nerve autograft and exceeds those for tube conduit. Continuation of this study will provide additional clinical data to further define the expected outcomes of processed nerve allografts in complex nerve reconstructions.


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