Elsevier

The Journal of Hand Surgery

Volume 37, Issue 11, November 2012, Pages 2340-2349
The Journal of Hand Surgery

Scientific article
Functional Outcome Following Nerve Repair in the Upper Extremity Using Processed Nerve Allograft

https://doi.org/10.1016/j.jhsa.2012.08.028Get rights and content

Purpose

Reconstruction of peripheral nerve discontinuities with processed nerve allograft has become increasingly relevant. The RANGER Study registry was initiated in 2007 to study the use of processed nerve allografts in contemporary clinical practice. We undertook this study to analyze outcomes for upper extremity nerve repairs contained in the registry database.

Methods

We identified an upper extremity–specific population within the RANGER Study registry database consisting of 71 nerves repaired with processed nerve allograft. This group was composed of 56 subjects with a mean age of 40 ± 17 years (range, 18–86 y). We analyzed data to determine the safety and efficacy of processed nerve allograft. Quantitative data were available on 51 subjects with 35 sensory, 13 mixed, and 3 motor nerves. The mean gap length was 23 ± 12 mm (range, 5–50 mm). We performed an analysis to evaluate response-to-treatment and to examine sensory and motor recovery according to the international standards for motor and sensory nerve recovery.

Results

There were no reported implant complications, tissue rejections, or adverse experiences related to the use of the processed nerve allografts. Overall recovery, S3 or M4 and above, was achieved in 86% of the procedures. Subgroup analysis demonstrated meaningful levels of recovery in sensory, mixed, and motor nerve repairs with graft lengths between 5 and 50 mm. The study also found meaningful levels of recovery in 89% of digital nerve repairs, 75% of median nerve repairs, and 67% of ulnar nerve repairs.

Conclusions

Our data suggest that processed nerve allografts offer a safe and effective method of reconstructing peripheral nerve gaps from 5 to 50 mm in length. These outcomes compare favorably with those reported in the literature for nerve autograft, and exceed those reported for tube conduits.

Type of study/level of evidence

Therapeutic III.

Section snippets

Study design

We performed this investigation and the RANGER Study registry in accordance with our institutional review boards and Good Clinical Practices.11 All consenting adult subjects implanted with the processed allograft were eligible for the study. We used standardized data capture forms to normalize information from the charts of subjects. Chart reviews were completed in a retrospective fashion to collect subject, injury, and repair demographics as well as outcome measures from surgeon, nursing, and

Results

We conducted an analysis for improvement in nerve function for all subjects based on the last reported follow-up visit. We observed improvement in sensory or motor function in 89% of repairs. There were no reported implant complications, tissue rejections, or adverse events related to the use of the processed nerve allografts. Four injuries (6%) underwent revision. Upon reexploration, 2 subjects had foreign bodies (ie, glass fragments) remaining in the wound bed and 2 subjects reported

Discussion

As an alternative to the classic nerve autograft or hollow tube conduit, nerve allografts provide organized microarchitecture, extracellular matrix constituents, and handling qualities of nerve autograft with the benefit and convenience of an off-the-shelf graft.13, 14 In 1885, Albert15 described nerve gap reconstitution with whole allograft nerve. Although the concept remained attractive, it was hampered by the need to mitigate the patient's immune response.13, 14 The advent of tissue

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  • Cited by (0)

    Supported by AxoGen, Inc., Alachua, Florida.

    No benefits in any form have been received or will be received related directly or indirectly to the subject of this article.

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