An interventional study of Polynerve in Injury of Nerves at Wrist and Hand Level, sponsored by University of Manchester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-01.
Sponsored by University of Manchester · Not applicable, Interventional, and Treatment
Participants with a traumatic sensory nerve injury in the hand will be recruited to the study. Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve. Participants will be followed up regularly, observed for device-related complications and to assess the return of sensory innervation.
Peripheral nerve injuries are a common occurrence, with approximately 9000 cases in the United Kingdom (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 .
Despite advances in microsurgical nerve repair techniques, functional recovery is often poor e.g. resulting impaired hand sensation, reduced motor function and frequent 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.
Peripheral nerve injury usually presents with nerve stumps that can be approximated in surgical repair: direct, end-to-end suture repair of the epineurium (neurorrhaphy). Excessive tension over the suture line leads to poor results; therefore when the nerve stumps cannot be approximated without tension, an alternative surgical method is required.
Where the nerve gap exceeds more than 5 mm, there are two fundamental options, either 'nerve grafting' or 'tubulisation' using a bridging material. This trial 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. Polynerve is a degradable co-polymer of Poly ε-caprolactone (PCL) and Poly (L-lactic acid) (PLA) which is shaped as a cylinder with a novel internal lumen consisting of a specific micro-grooved architecture.
91 studies on the registry are indexed under Peripheral Nerve Injuries; 22 are open to participants now.
This study's enrollment of 17 is below the median of 44 across 61 interventional studies indexed under Peripheral Nerve Injuries.
Browse Peripheral Nerve Injuries studies →University of Manchester is the lead sponsor of 201 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve.
Device: Polynerve
Polymer biomaterial nerve conduit
Assessment of safety and tolerability: number of patients with treatment-related adverse events as assessed by the Clavien-Dindo classification of surgical complications
To assess the safety and tolerability of use of the polymer biomaterial nerve conduit to repair a sensory nerve transection of the hand
Time frame: 1 year
Measurement of efficacy: Sensory nerve function measured by two-point discrimination (2PD), the Weinstein Enhanced Sensory Test (WEST) monofilaments, and locognosia
To measure efficacy of the polymer biomaterial nerve conduit to support nerve regeneration following the transection of the sensory nerve of the hand
Time frame: 1 year
Ran from Aug 2017 to primary completion in Aug 2019, 24 months.
Of 22 interventional studies with no phase under Peripheral Nerve Injuries, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14. This study's 24 months is below that.
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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