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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 : October 26, 2018
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Adam Reid, University of Manchester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Injury of Nerves at Wrist and Hand Level Device: Polynerve Not Applicable

Detailed Description:

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)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Polynerve
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any trial specific procedures
  2. Traumatic injury/injuries to the hand with clinical suspicion of sensory nerve transection mandating surgical exploration
  3. Male and females aged 18-80

Exclusion Criteria:

  1. Concomitant injuries requiring surgical treatment from other specialists
  2. 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)
  3. A stated hypersensitivity or allergy to the polymers PCL/PLA
  4. Any other significant co-morbidity impacting on the risk of surgery (to be determined by the multi-disciplinary team (MDT))
  5. Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days.

Information from the National Library of Medicine

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


Locations
United Kingdom
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Wythenshawe, Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
University of Manchester
National Institute for Health Research, United Kingdom
Investigators
Study Chair: Adam Reid University of Manchester

Responsible Party: Adam Reid, Chief Investigator, University of Manchester
ClinicalTrials.gov Identifier: NCT02970864     History of Changes
Other Study ID Numbers: R116863
2016-001667-37 ( EudraCT Number )
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adam Reid, University of Manchester:
Nerve regeneration
Peripheral nerve injury
Nerve conduits
Sensory nerve transection

Additional relevant MeSH terms:
Wounds and Injuries