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BioMed Research International
Volume 2014, Article ID 121452, 11 pages
http://dx.doi.org/10.1155/2014/121452
Research Article

The Proximal Medial Sural Nerve Biopsy Model: A Standardised and Reproducible Baseline Clinical Model for the Translational Evaluation of Bioengineered Nerve Guides

1Department of Plastic Surgery, Reconstructive and Hand Surgery, Burn Centre, Medical Faculty, RWTH Aachen University Hospital, Pauwelsstraße 30, 52074 Aachen, Germany
2Department of Neurology, Medical Faculty, RWTH Aachen University, 52074 Aachen, Germany
3Institute of Neuropathology, RWTH Aachen University Hospital, 52074 Aachen, Germany
4JARA, Translational Brain Medicine, 52074 Aachen, Germany
5Clinical Trial Center Aachen (CTC-A), Medical Faculty, RWTH Aachen University Hospital, 52074 Aachen, Germany

Received 7 February 2014; Revised 13 April 2014; Accepted 14 April 2014; Published 2 June 2014

Academic Editor: Stefano Geuna

Copyright © 2014 Ahmet Bozkurt et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Autologous nerve transplantation (ANT) is the clinical gold standard for the reconstruction of peripheral nerve defects. A large number of bioengineered nerve guides have been tested under laboratory conditions as an alternative to the ANT. The step from experimental studies to the implementation of the device in the clinical setting is often substantial and the outcome is unpredictable. This is mainly linked to the heterogeneity of clinical peripheral nerve injuries, which is very different from standardized animal studies. In search of a reproducible human model for the implantation of bioengineered nerve guides, we propose the reconstruction of sural nerve defects after routine nerve biopsy as a first or baseline study. Our concept uses the medial sural nerve of patients undergoing diagnostic nerve biopsy (≥2 cm). The biopsy-induced nerve gap was immediately reconstructed by implantation of the novel microstructured nerve guide, Neuromaix, as part of an ongoing first-in-human study. Here we present (i) a detailed list of inclusion and exclusion criteria, (ii) a detailed description of the surgical procedure, and (iii) a follow-up concept with multimodal sensory evaluation techniques. The proximal medial sural nerve biopsy model can serve as a preliminarynature of the injuries or baseline nerve lesion model. In a subsequent step, newly developed nerve guides could be tested in more unpredictable and challenging clinical peripheral nerve lesions (e.g., following trauma) which have reduced comparability due to the different nature of the injuries (e.g., site of injury and length of nerve gap).