Comparing NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Repairing Peripheral Nerve Injuries in Adults

What this Trial Is About

This trial evaluates treatments for peripheral nerve injuries with gaps between 0.5 and 3.0 cm in adults aged 18 to 80. Researchers compare the efficacy of the NeuroSpan Bridge device against the NeuraGen Nerve Guide and Nerve Autograft in repairing nerve discontinuities. The study is conducted as a multicenter, prospective, randomized, double-blinded clinical trial to assess treatment outcomes and safety. Participants receive one of three nerve repair treatments based on the size of their nerve injury. Those with injuries 0.5 to 1.0 cm receive the NeuraGen Nerve Guide, a resorbable implant that supports nerve repair. Injuries 1.1 to 3.0 cm are repaired using a nerve autograft, transplanting the patients own sensory nerve tissue. The NeuroSpan Bridge, a novel scaffold device designed to mimic natural nerve architecture and support axonal growth across nerve gaps, is also being studied as a treatment option. Throughout the 12-month study period, participants are assessed for nerve function and safety outcomes. Measurements include static two-point discrimination, motor and sensory function grading, moving two-point discrimination, and scores from the Disabilities of the Arm Shoulder and Hand DASH questionnaire. Safety monitoring covers complications such as infections, inflammation, tissue rejection, neuroma formation, chronic pain, and device malfunctions. The trial aims to gather comprehensive data on the effectiveness and safety of these nerve repair methods.

A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair