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Protocol for a phase I trial of a novel synthetic polymer nerve conduit 'Polynerve' in participants with sensory digital nerve injury (UMANC).

ABSTRACT: Background: Peripheral nerve injuries are common, with approximately 9,000 cases in the UK annually. Young working individuals are predominantly affected, leading to significant health and social implications. Functional recovery is often poor with impaired hand sensation, reduced motor function and pain and cold intolerance. Where a nerve gap exists, nerve grafting remains the gold-standard treatment but creates a second surgical site, sensory deficit at the donor site, possible neuroma formation and has limited availability. Current commercially available synthetic and resorbable nerve conduit alternatives are reported to be rigid and inflexible. This study will set out to 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-?-caprolactone and poly-l-lactic acid, which is shaped as a cylinder that has greater tensile strength, flexibility and less acidic degradation compared with current commercially available synthetic nerve conduits. In addition, it has a novel micro-grooved internal lumen that aids Schwann cell ingress and alignment to improve nerve regeneration. Methods: In total, 17 eligible participants will be recruited to undergo repair of a transected sensory nerve of the hand using the Polynerve device. All participants that receive the nerve conduit device will be followed for a period of 12 months post-surgery. The primary endpoint is safety of the device and the secondary endpoint is degree of sensory nerve regeneration through the conduit assessed using standard sensory testing (2-PD, WEST monofilament testing and locognosia). Discussion: The 'UMANC' trial is a single-centre UK-based, prospective, unblinded, phase I clinical trial of a novel nerve conduit device. We aim to demonstrate the safety of Polynerve as a synthetic, biodegradable nerve conduit and improve the treatment options available to patients with significant nerve injuries. Registration: Clinicaltrials.gov: NCT02970864; EudraCT: 2016-001667-37.

SUBMITTER: Murphy R

PROVIDER: S-EPMC7355221 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Protocol for a phase I trial of a novel synthetic polymer nerve conduit 'Polynerve' in participants with sensory digital nerve injury (UMANC).

Murphy Ralph R Faroni Alessandro A Wong Jason J Reid Adam A

F1000Research 20190624

<b>Background:</b> Peripheral nerve injuries are common, with approximately 9,000 cases in the UK annually. Young working individuals are predominantly affected, leading to significant health and social implications. Functional recovery is often poor with impaired hand sensation, reduced motor function and pain and cold intolerance. Where a nerve gap exists, nerve grafting remains the gold-standard treatment but creates a second surgical site, sensory deficit at the donor site, possible neuroma ...[more]

PMID: 32685131

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Project description:BackgroundCurrent repair options for peripheral nerve injuries where tension-free gap closure is not possible include allograft, processed nerve allograft, and hollow tube conduit. Here we report on the outcomes from a multicenter prospective, randomized, patient- and evaluator-blinded, pilot study comparing processed nerve allograft and hollow conduit for digital nerve reconstructions in the hand.MethodsAcross 4 centers, consented participants meeting inclusion criteria while not meeting exclusion criteria were randomized intraoperatively to either processed nerve allograft or hollow conduit. Standard sensory and safety assessments were conducted at baseline, 1, 3, 6, 9, and 12 months after reconstruction. The primary outcome was static 2-point discrimination (s2PD) testing. Participants and assessors were blinded to treatment. The contralateral digit served as the control.ResultsWe randomized 23 participants with 31 digital nerve injuries. Sixteen participants with 20 repairs had at least 6 months of follow-up while 12-month follow-up was available for 15 repairs. There were no significant differences in participant and baseline characteristics between treatment groups. The predominant nerve injury was laceration/sharp transection. The mean ± SD length of the nerve gap prior to repair was 12 ± 4 mm (5-20 mm) for both groups. The average s2PD for processed allograft was 5 ± 1 mm (n = 6) compared with 8 ± 5 mm (n = 9) for hollow conduits. The average moving 2PD for processed allograft was 5 ± 1 mm compared with 7 ± 5 mm for hollow conduits. All injuries randomized to processed nerve allograft returned some degree of s2PD as compared with 75% of the repairs in the conduit group. Two hollow conduits and one allograft were lost due to infection during the study.ConclusionsIn this pilot study, patients whose digital nerve reconstructions were performed with processed nerve allografts had significantly improved and more consistent functional sensory outcomes compared with hollow conduits.

Project description:ObjectivesA systematic review to assess the evidence supporting surgical repair of digital nerve injury versus no repair in adults in terms of clinical outcomes.DesignA Preferred Reporting Items for Systematic Reviews and Meta-Analyses-compliant systematic review with methodology based on the Cochrane Handbook of Systematic Reviews of Interventions.Data sourcesDatabases included OvidMEDLINE, EMBASE, AMED, clinicaltrials.gov and the Cochrane Database of Systematic Reviews, searched from inception until 10 November 2018.Eligibility criteriaAdult digital nerve injury in which either direct repair or no repair was undertaken and an outcome measure was recorded.Data extraction and synthesisStudy data extracted included demographics, injury type and extent, timing, treatment details, outcome data and time points, adverse outcomes, hand therapy and return to work. The National Institute of Health quality assessment tool for case series was used to assess risk of bias.ResultsThirty studies were included. One compared surgical repair with non-repair. All studies were case series of between 15 and 110 nerve injuries, with heterogeneous patient, injury and treatment characteristics. Two studies detailed nerve repair without magnification. Static 2-point discrimination (s2PD) was the most commonly reported outcome measure. Return of protective sensation was achieved in most cases in the nerve repair and no nerve repair groups. Repair resulted in better s2PD than no repair, but <25% repaired nerves achieved normal levels. Adverse outcomes were similar between repair and no repair groups.ConclusionsOnly level IV evidence is available to support surgical repair of digital nerves in adults. Return of normal sensibility is uncommon and almost all unrepaired nerves regained protective sensation by 6 months and all patients declined further surgery. There was no difference in adverse outcomes. There is currently a lack of high-quality evidence to support surgical repair of digital nerve injuries in adults and further research is needed.Prospero registration numberCRD42017065092.

Dataset Information

Protocol for a phase I trial of a novel synthetic polymer nerve conduit 'Polynerve' in participants with sensory digital nerve injury (UMANC).

Publications

Protocol for a phase I trial of a novel synthetic polymer nerve conduit 'Polynerve' in participants with sensory digital nerve injury (UMANC).

Similar Datasets

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