CC BY-NC-ND 4.0 · Journal of Reconstructive Microsurgery Open 2021; 06(01): e1-e10
DOI: 10.1055/s-0040-1722201
Original Article

Neuroma Prevention and Implantation Effects of NEUROCAP in Rat Sciatic Nerve Model

Steven L. Peterson
1  Portland VA Medical Center, Portland, Oregon
,
Harm de Vries
2  Polyganics, Groningen, The Netherlands
,
Kami Collins
3  NAMSA, Brooklyn Park, Minnesota
,
Hilde Geraedts
2  Polyganics, Groningen, The Netherlands
,
Michael J. Wheatley
4  Kaiser Permanente NW, Portland, Oregon
› Author Affiliations

Abstract

Introduction Symptomatic neuroma with neuropathic pain can develop following peripheral nerve injury. Current interventions for symptomatic neuroma have unpredictable results. NEUROCAP (Polyganics, Groningen, The Netherlands) is a bioresorbable nerve capping device intended to protect a peripheral nerve end and separate the nerve from the surrounding environment, to prevent the recurrence of a symptomatic neuroma.

Materials and Methods This study aims to assess the implantation effects of the NEUROCAP device in a rat sciatic nerve model during 12 months (±2 days). Forty-one adult male Sprague-Dawley rats were used in this study. They were randomly divided into a capping or test group, or a noncapping or control group for different time points of survival (12 weeks, 6 months, and 12 months). The objective of this study was evaluated regarding procedural data, adverse events, clinical observations, and histopathology.

Results The overall general health of the animals was adequate throughout the study, with the exception of autotomy during the first 4 months of survival. Eight animals were euthanized early due to autotomy, excluded from the study and seven of them have been replaced. Autotomy was an expected outcome and a known limitation of the animal model, particularly as this was a full sciatic nerve transection model. Neuroma formation was observed in the control group while there was no neuroma formation present in the test group. The control group showed increased nerve outgrowth and more chaotic fascicles in comparison with the test group. The test group also had a higher percentage of myelinated fibers compared to the control group. These results indicate a preventive mode of action of the NEUROCAP with regard to neuroma formation after nerve transection in a rat sciatic nerve model.

Conclusion The results indicate that NEUROCAP is safe and effective in preventing the recurrence of neuroma formation and inhibiting nerve outgrowth.



Publication History

Received: 29 October 2019

Accepted: 01 November 2020

Publication Date:
08 January 2021 (online)

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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