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
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
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