A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury (UMANC)
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|ClinicalTrials.gov Identifier: NCT02970864|
Recruitment Status : Active, not recruiting
First Posted : November 22, 2016
Last Update Posted : November 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Injury of Nerves at Wrist and Hand Level||Device: Polynerve||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury|
|Actual Study Start Date :||August 17, 2017|
|Actual Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 2021|
Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the 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 [ Time Frame: 1 year ]To assess the safety and tolerability of use of the polymer biomaterial nerve conduit to repair a sensory nerve transection of the hand
- Measurement of efficacy: Sensory nerve function measured by two-point discrimination (2PD), the Weinstein Enhanced Sensory Test (WEST) monofilaments, and locognosia [ Time Frame: 1 year ]To measure efficacy of the polymer biomaterial nerve conduit to support nerve regeneration following the transection of the sensory nerve of the hand
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970864
|Wythenshawe Hospital, Manchester University NHS Foundation Trust|
|Wythenshawe, Manchester, United Kingdom, M23 9LT|
|Study Chair:||Adam Reid||University of Manchester|