Reconstruction of Upper Extremity Peripheral Nerve Injuries Using an Epineurial-Like Collagen Device—A Prospective Clinical Study

Abstract

Abstract Background Epineurium acts as a barrier to protect nerves from injury and maintains its structural and functional integrity. A device was developed to mimic the native structure of epineurium. The aim of this study was to evaluate its biological characteristics and clinical performance in the reconstruction of upper extremity peripheral nerves. Methods Scanning electron microscopy, transmission electron microscopy, and enhanced microcomputed tomography were used to examine the ultrastructural characteristics of the device. A prospective case series with 2-year follow-up was undertaken and reported. Patients who required nerve reconstruction in the upper extremities were included and underwent single or multiple nerve reconstructions in one or both upper limbs. Results The device mimics the structural and biological properties of epineurium. During surgical use, it can form compression-free and self-engaged wrapping around the repaired nerves. A total of 36 peripheral nerve reconstructions were performed using either nerve transfer or nerve grafting in 19 patients. Of these, 14 patients had upper limb nerve injuries and 5 had C5 to C8 spinal cord injuries resulting in tetraplegia. Nerve reconstruction using the device restored peripheral nerve function, with functional motor recovery (FMR) observed in 76% of the most proximal target muscle at 12 months and 85% of most proximal muscles at 24 months post-treatment. FMR was observed in 61% of all target muscles at 12 months and 75% at 24 months post-treatment. Conclusion The device restored FMR in the upper extremities in patients with peripheral nerve or spinal cord injuries. Level of Evidence Therapeutic IV