Neuroma Prevention and Implantation Effects of NEUROCAP in Rat Sciatic Nerve Model
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.
Keywordssymptomatic end-neuroma - rat sciatic nerve model - nerve-capping experimental design - NEUROCAP
Received: 29 October 2019
Accepted: 01 November 2020
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/)
Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA
- 1 Laing T, Siddiqui A, Sood M. The management of neuropathic pain from neuromas in the upper limb: surgical techniques and future directions. Plast Aesth Res 2015; 2 (04) 165-170
- 2 Harden RN. Chronic neuropathic pain. Mechanisms, diagnosis, and treatment. Neurologist 2005; 11 (02) 111-122
- 3 Vernadakis AJ, Koch H, Mackinnon SE. Management of neuromas. Clin Plast Surg 2003; 30 (02) 247-268 , vii
- 4 Balcin H, Erba P, Wettstein R, Schaefer DJ, Pierer G, Kalbermatten DF. A comparative study of two methods of surgical treatment for painful neuroma. J Bone Joint Surg Br 2009; 91 (06) 803-808
- 5 Guse DM, Moran SL. Outcomes of the surgical treatment of peripheral neuromas of the hand and forearm: a 25-year comparative outcome study. Ann Plast Surg 2013; 71 (06) 654-658
- 6 Biazar E, Khorasani MT, Montazeri N. et al. Types of neural guides and using nanotechnology for peripheral nerve reconstruction. Int J Nanomedicine 2010; 5: 839-852
- 7 Bertleff MJ, Meek MF, Nicolai JP. A prospective clinical evaluation of biodegradable neurolac nerve guides for sensory nerve repair in the hand. J Hand Surg Am 2005; 30 (03) 513-518
- 8 Lewin-Kowalik J, Marcol W, Kotulska K, Mandera M, Klimczak A. Prevention and management of painful neuroma. Neurol Med Chir (Tokyo) 2006; 46 (02) 62-67 , discussion 67–68
- 9 Stoll G, Müller HW. Nerve injury, axonal degeneration and neural regeneration: basic insights. Brain Pathol 1999; 9 (02) 313-325
- 10 Theodosiou M, Rush RA, Zhou XF, Hu D, Walker JS, Tracey DJ. Hyperalgesia due to nerve damage: role of nerve growth factor. Pain 1999; 81 (03) 245-255
- 11 Nordin M, Nyström B, Wallin U, Hagbarth KE. Ectopic sensory discharges and paresthesiae in patients with disorders of peripheral nerves, dorsal roots and dorsal columns. Pain 1984; 20 (03) 231-245
- 12 Maggi SP, Lowe III JB, Mackinnon SE. Pathophysiology of nerve injury. Clin Plast Surg 2003; 30 (02) 109-126
- 13 Otfinowski J, Pawelec A, Kałuza J. Implantation of peripheral neural stump into muscle and its effect on the development of posttraumatic neuroma. Pol J Pathol 1994; 45 (03) 195-202
- 14 Herndon JH. Neuromas. In: Green DP, Hotchkiss RN. eds. Operative Hand Surgery. Edinburgh: Churchill Livingstone; 1993: 1387-1400
- 15 Taneerananon T, Hussain MA, Jhattu H, Li J, Klaassen M, Milovic V. Use of poly dl-lactide-ε-caprolactone (Neurolac) conduit for enveloping traumatic neuromas. Eur J Plast Surg 2013; 36 (10) 657-660
- 16 Barett S, Zgonis T. Nerve-Related Injuries and Treatments for the Lower Extremity. PA: Elsevier; 2016. ;(033)2: 239-240
- 17 Sunderland S. The connective tissues of peripheral nerves. Brain 1965; 88 (04) 841-854
- 18 Zeltser R, Beilin B, Zaslansky R, Seltzer Z. Comparison of autotomy behavior induced in rats by various clinically-used neurectomy methods. Pain 2000; 89 (01) 19-24