A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury

Conditions
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Injury of Nerves at Wrist and Hand Level

Intervention / Treatment
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* Device: Polynerve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any trial specific procedures Traumatic injury/injuries to the hand with clinical suspicion of sensory nerve transection mandating surgical exploration Male and females aged 18-80 Exclusion Criteria: Concomitant injuries requiring surgical treatment from other specialists Specified co-morbidities that would increase a participants risk of infection including diabetes, renal/liver disease, autoimmune diseases, primary or secondary immunocompromised participants (including immunosuppressive drugs or known disease resulting in suppressed immunity) A stated hypersensitivity or allergy to the polymers PCL/PLA Any other significant co-morbidity impacting on the risk of surgery (to be determined by the multi-disciplinary team (MDT)) Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polynerve<br>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<br>* Polymer biomaterial nerve conduit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nerve regeneration, Peripheral nerve injury, Nerve conduits, Sensory nerve transection