Performance Study of an Artificial Nerve Guide (Reaxon® Nerve Guide) to Treat Digital Nerve Lesions

Medovent

Status: Terminated

Conditions: Peripheral Nerve Injuries

Treatments: Device: Implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02459015

NG-001

Details and patient eligibility

About

The purpose of this clinical investigation is to confirm the medium- and long-term safety and performance of the chitosan-based nerve guide (Reaxon® Nerve Guide) in comparison to an autologous nerve graft to bridge nerve defects in the finger.

Full description

The clinical investigation NG-001 is a multicenter, parallel, controlled, randomized, blind evaluation of the repair of digital nerve lesions.

Medovent will perform this clinical investigation as a post-market clinical follow-up (PMCF) study in accordance with the MEDDEV 2.12/2 rev2 guidelines to confirm the medium- and long-term safety and performance of its chitosan-based nerve guide (Reaxon® Nerve Guide). The results of this investigation will be used by Medovent to update the clinical evaluation throughout the life-cycle of Reaxon® Nerve Guide and to ensure its long term safety and performance in the market. Additionally, Medovent will include the application of Reaxon® Nerve Guide in digital nerves to confirm the safety of applying Reaxon® Nerve Guide over joints.

The study will be performed in specialized German centers. A total number of 76 subjects with traumatic digital nerve injuries in whom surgical repair may not allow end-to-end direct suture of the nerve ends, and in whom the nerve tissue gap would indicate the use of an autograft of equal or less than 26 mm, are eligible for inclusion.

The primary objective of the clinical investigation is to demonstrate that the static 2-point discrimination (2-PD) 12 months after surgery will be not inferior in the Reaxon® Nerve Guide test group compared to the control group receiving an autologous nerve graft.

The secondary objective is to document the long-term effects (up to 18 months after surgery) in nerve repair. The non-inferiority test is to demonstrate that it can be excluded that the treatment difference is larger than 20% in favor for the control group.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. males and females between 18 and 65 years of age able to give his/her consent
2. a complete traumatic nerve injury of the common or proper digital nerve in the hand
3. a nerve defect of less or equal than 26 mm after release and approximation of the nerve ends and measured when the wrist is in neutral position
4. an injury that could conventionally be treated with implantation of a short nerve graft
5. nerve treatment initiated until 3 months after nerve injury
6. signed informed consent

Exclusion criteria

1. known allergy to chitosan and/or polyvinylpyrrolidone (PVP)
2. known impairment / previous diseases of the neural axis or previous lesions of the affected hand (of the digital nerve), which led to permanent sensory or motor restrictions of the hand/finger
3. complete amputation injury
4. known pregnant or breast-feeding females
5. disorders known leading to impaired wound healing (e.g. diabetes mellitus)
6. skin diseases in the wound area
7. impaired blood coagulation or bleeding disorders (e.g. because of regular intake of cumarin such as Marcumar)
8. pathologic blood flow disorders (e.g. Morbus Raynaud)
9. participated in another clinical investigation using an investigational new drug or device within 30 days prior to enrolment into this investigation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Reaxon® Nerve Guide

Experimental group

Description:

Implantation of Reaxon® Nerve Guide: If the subject is randomized to the Reaxon® Nerve Guide group, the surgeon will implant a Reaxon® Nerve Guide of ≤ 30 mm to bridge a nerve defect of ≤ 26 mm according to the method described in the instructions for use.

Treatment:

Device: Implantation

Autologous Nerve Graft

Active Comparator group

Description:

Implantation of an autologous nerve graft: If the subject is randomized to the conventional treatment, the surgeon will repair the nerve by interposing an autologous nerve graft of ≤ 26 mm between the nerve ends.

Treatment:

Device: Implantation