The 2004 Annual Meeting (January 14-20, 2004) of OASYS_NEW

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A Randomized Prospective Multicenter Study of a Biodegradable Neurolac® Nerve Guide for Sensory Nerve Repair in the Hand

Meek MF1, Bertleff MJOE1, Ritt MJPF2, Van der Lei B3, De Boer A4, Houpt P5, and Nicolai J-PA1. (1) Plastic Surgery, University Hospital Groningen, Hanzeplein 1, Groningen, Netherlands, (2) Plastic Surgery, VU University Medical Center Amsterdam, Amsterdam, Netherlands, (3) Department of Plastic Surgery, Medical Center Leeuwarden, Leeuwarden, Netherlands, (4) Department of Plastic Surgery, Martini Hospital Groningen, Groningen, Netherlands, (5) Department of Plastic Surgery, Sophia Hospital Zwolle, Zwolle, Netherlands

Introduction: Injury of peripheral nerves is a common problem, and is always associated with loss of nerve function. Current repair techniques include direct end-to-end suturing or interposition of autologous nerve grafts. The preferred technique to repair peripheral nerve gaps without tension is autologous nerve grafting. This technique is without problems, but the results are less satisfactory and leads to donor site morbidity. An alternative method for peripheral nerve repair is the use of nerve conduits. The aim of nerve conduits is to guide regenerating nerve fibers towards the distal nerve stump, whilst neuroma formation and ingrowth of fibrous tissue into the nerve gap is prevented. Since 1989 we obtained experience with the application of a degradable nerve guide composed of poly (DL lactide-e-caprolactone).

Purpose: The purpose of this randomized prospective multicenter study is to compare the Neurolac® nerve guide (Polyganics BV, Groningen, The Netherlands) with standard nerve repair (i.e. either autologous nerve grafting or end-to-end repair) for sensory nerve defects in the hand.

Methods: From August 2002 to May 2003 52 patients have been randomized in this prospective multicenter study. Patients with a sensory nerve defect in the hand, meeting the selection criteria, were either treated with a Neurolac nerve guide or according to current practice (nerve grafting or end-to-end repair). Quantitative sensory testing using the Pressure-Specified Sensory DeviceTM (PSSD, Sensory Management Services Inc, Baltimore, USA) is being performed in all patients at three-month intervals for a one-year follow-up period to evaluate sensory nerve recovery.

Results: 52 patients have been included. Thusfar device-related severe adverse events were not reported. At three months, sensory nerve recovery has been observed in both arms of the study. At the end of the year 2003 we are able to present the 6 months data of sensory nerve recovery of all patients.

Conclusion: The preliminary short-term results indicate that the Neurolac® nerve guide can be safely used for the repair of sensory nerve defects in the hand. The patients will be further followed in order to obtain long-term data of sensory nerve recovery in both the experimental and control groups.


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