gms | German Medical Science

Objectives/Interrogation: Microsurgical repair of the injured digital nerve is considered to be the gold standard. Complications associated with neurorrhaphy include repair site scar and neuroma formation estimated at 5-9%. The CoNNECT study is a randomised controlled trial evaluating nerve repair using a Neurolac conduit (Polyganics) as an adjunct to microneurorrhaphy or as a detensioning sutureless nerve co-aptation.

Methods: Patients were recruited from a tertiary referral regional hand trauma service. Patients with sensory loss following an open injury were screened for eligibility then recruited and consented for trial participation. Confirmation of second stage eligibility was after surgical exploration and at that stage complete digital nor common digital nerve injuries amenable to direct repair were randomised in a 1:1:1 ratio (direct repair; repair plus conduit; conduit alone). Patients were assessed at 2 weeks, 6 weeks, 3 months and 6 months by a research hand therapist with DASH scores plus sensory evaluation using 2PD and monofilaments. Complications including clinically suspected neuroma, pain and cold intolerance were recorded.

Results and Conclusions: 63 patients with 73 nerve injuries have reached at least 6 months follow up under the study protocol. There have been no post-operative infections, conduit extrusions, allergic reactions or explantations during the study. No clinically suspected neuromas have been identified in the 73 nerves reaching 6 month follow-up.

The study is powered for 240 digital nerve repairs to allow for drop-out. The final sensory outcomes will be reported after closure of the recruitment period. The interim analysis of 73 nerves is part of the trial data monitoring and to date there are no adverse events attributable to the implanted Neurolac device. The study will be one of the largest randomised controlled trials evaluating digital nerve repair and will evaluate efficacy of a sutureless technique in nerve co-aptation.