Clinical trial NCT02459015: Performance Study of an Artificial Nerve Guide (Reaxon® Nerve Guide) to Treat Digital Nerve Lesions
Official title: A Controlled, Randomized, Comparison, Blind Evaluation of Repair of Digital Nerve Lesions in Man Using an Implanted Reaxon® Nerve Guide
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Nerve Injuries
Lead sponsor: Medovent GmbH
Sponsor class: INDUSTRY
First posted: 2015-06-01
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Static 2-point discrimination (2-PD)
timeFrame: Primary outcome analysis will be performed from the clinical evaluations at 12 months post-surgery
Secondary outcomes:
measure: Static 2-point discrimination (2-PD)
timeFrame: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
measure: Moving 2-PD
timeFrame: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
measure: Semmes-Weinstein Monofilament
timeFrame: Follow-up examinations 3, 6, 12 and 18 months post-surgery
measure: Subject's estimation of cold intolerance and hyperesthesia
timeFrame: Follow-up examinations 3, 6, 12 and 18 months post-surgery
measure: Hoffmann-Tinel-Test
timeFrame: Follow-up examinations 3, 6, 12 and 18 months post-surgery
measure: post-operative complications
timeFrame: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Other outcomes:
Locations:
city: Halle
country: Germany
facility: BG-Kliniken Bergmannstrost
state: Sachsen-Anhalt
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Hamburg
country: Germany
facility: BG Kliniken Hamburg gGmbH
Study officials:
affiliation: BG-Kliniken Bergmannstrost
name: Frank Siemers, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: