gms | German Medical Science

Objectives/Interrogation: The gold standard treatment for a complete traumatic peripheral nerve lesion involves direct end-to-end microsurgical repair. Repair with higher magnification improve the macroscopic appearance and the potential for improved neurological regeneration. Conduits are established for bridging small gaps in peripheral nerves to avoid interposition grafts or suture with tension. The objective of this study is to evaluate the recovery following repair of digital nerves within the hand treated with direct microsurgical suture, suture with nerve conduits augmentation or nerve conduits apposition with remote suture distal to the injury site

Methods: A multi centre randomised controlled trial with three parallel groups and blinding of patient and assessing hand therapist will be conducted at a tertiary referral centre for the management of hand and peripheral nerve injuries in the UK. The study will enrol participants with traumatic injuries to the digital or common digital nerves within the hand and randomisation in a 1:1:1 ratio for each nerve injury. They will be stratified according to the age group. The power analysis estimates 62 nerves recruited to each group to demonstrate equivalence. 240 nerves will be recruited to allow a drop out of 30% with the modified Weber scale as a primary outcome measure of sensory recovery using static and moving two point discrimination at 12 months

Results and Conclusions: We present the data and results from our trial tat has been recruiting since August 2017 of over 50 patients.

The challenges that are faced in running the trial and also our experience in setting up multi-centre randomised controlled trials at the Birmingham Hand Centre.