UMANC

  • Research type

    Research Study

  • Full title

    A Phase I study of a novel synthetic polymer nerve conduit ‘Polynerve’ in patients with sensory digital nerve injury

  • IRAS ID

    203219

  • Contact name

    Adam Reid

  • Contact email

    adam.reid@manchester.ac.uk

  • Sponsor organisation

    The University of Manchester

  • Clinicaltrials.gov Identifier

    NCT02970864

  • Duration of Study in the UK

    1 years, 11 months, 31 days

  • Research summary

    This study will examine the first-in-man use of a new nerve conduit device ‘Polynerve’ to repair small nerve gaps in digital sensory nerves of the hand. In this study we will establish whether the ’Polynerve’ is safe to used as a new nerve conduit device and whether the ’Polynerve’ supports nerve regeneration.\n\nPeripheral nerve injuries are a common occurrence, with approximately 9000 cases in the UK occurring each year. Most are in a predominantly young and working population. Where surgical reconstruction is required to repair the peripheral nerve injury, techniques employed have changed little in the last 50-60 years with many factors influencing the outcomes, such as age of patient, timing, level and extent of injury, method of repair and the surgeon’s skill.\n \nDespite advances in microsurgical nerve repair techniques, functional recovery is often poor e.g. resulting impaired hand sensation, reduced motor function and frequently pain and cold intolerance. This can have a profound and permanent impact on the patient’s recovery and subsequent quality of life. Nerve repair has significant health, social and cost implications with the treatment and rehabilitation of an employed person, estimated to be EUR 51,238.\n\nPeripheral nerve injury may manifest without gaps in the nerve or conversely may result in a gap between nerve stumps. Where the latter is the case, small gaps can be repaired by direct, end-to-end suture repair of the epineurium (neurorrhaphy), providing a tensionless repair can be achieved as excessive tension over the suture line leads to poor results. Where the nerve gap exceeds more than 5 mm and cannot be repaired without tension, there are two fundamental options, either ’nerve grafting’ or ’tubulisation’ using a bridging material.

  • REC name

    North West - Greater Manchester South Research Ethics Committee

  • REC reference

    17/NW/0111

  • Date of REC Opinion

    10 Apr 2017

  • REC opinion

    Further Information Favourable Opinion