Collagen Conduit Versus Microsurgical Neurorrhaphy: 2-Year Follow-Up of a Prospective, Blinded Clinical and Electrophysiological Multicenter Randomized, Controlled Trial

Abstract

To compare repair of acute lacerations of mixed sensory-motor nerves in humans using a collagen tube versus conventional repair. In a prospective randomized trial, we repaired the ulnar or the median nerve with a collagen nerve conduit or with conventional microsurgical techniques. We enrolled 43 patients with 44 nerve lacerations. We performed electrophysiological tests and hand function using a standardized clinical evaluation instrument, the Rosen scoring system, after 12 and 24 months. Operation time using the collagen conduit was significantly shorter than for conventional neurorrhaphy. There were no complications in terms of infection, extrusion of the conduit, or other local adverse reaction. Thirty-one patients with 32 nerve lesions, repaired with collagen conduits or direct suture, attended the 24-month follow-up. There was no difference between sensory function, discomfort, or total Rosen scores. Motor scores were significantly better for the direct suture group after 12 months, but after 24 months, there were no differences between the treatment groups. There was a general further recovery of both motor and sensory conduction parameters at 24 months compared with 12 months. There were no statistically significant differences in amplitudes, latencies, or conduction velocities between the groups. Use of a collagen conduit produced recovery of sensory and motor functions that were equivalent to direct suture 24 months after repair when the nerve gap inside the tube was 6 mm or less, and the collagen conduit proved to be safe for these nerve lacerations in the forearm. Therapeutic II.