Study Stopped
The study was stopped due to slow patient recruitment and insufficient patient compliance.
Performance Study of an Artificial Nerve Guide (Reaxon® Nerve Guide) to Treat Digital Nerve Lesions
A Controlled, Randomized, Comparison, Blind Evaluation of Repair of Digital Nerve Lesions in Man Using an Implanted Reaxon® Nerve Guide
1 other identifier
interventional
46
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2015
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedJune 18, 2018
June 1, 2018
3 years
May 28, 2015
June 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Static 2-point discrimination (2-PD)
The perception of either one or two points of touch is assessed using a small tool with prongs at fixed spacing's from 2 to 15 mm. One or two points will be applied randomly in a longitudinal direction on the distal phalanx of all fingers. Grades/scores: 0 = \> 15 mm (poor) 1. = 11-15 mm (fair) 2. = 6-10 mm (good) 3. = \< 6 mm (excellent) Scores of 2 or 3 will be evaluated as (meaningful) response. At a score of 0 it will further be determined if the subject has protective sensibility or is anesthetic. A disposable cannula can be used. Single point is noticeable = protective sensibility No point is noticeable = anesthetic
Primary outcome analysis will be performed from the clinical evaluations at 12 months post-surgery
Secondary Outcomes (6)
Static 2-point discrimination (2-PD)
Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Moving 2-PD
Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Semmes-Weinstein Monofilament
Follow-up examinations 3, 6, 12 and 18 months post-surgery
Subject's estimation of cold intolerance and hyperesthesia
Follow-up examinations 3, 6, 12 and 18 months post-surgery
Hoffmann-Tinel-Test
Follow-up examinations 3, 6, 12 and 18 months post-surgery
- +1 more secondary outcomes
Study Arms (2)
Reaxon® Nerve Guide
EXPERIMENTALImplantation 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.
Autologous Nerve Graft
ACTIVE COMPARATORImplantation 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.
Interventions
A peripheral nerve defect up to 26 mm in the finger will be repaired by implantation of either a Reaxon® Nerve Guide or an autologous nerve graft (depending on the randomization group) on day 0.
Eligibility Criteria
You may qualify if:
- males and females between 18 and 65 years of age able to give his/her consent
- a complete traumatic nerve injury of the common or proper digital nerve in the hand
- 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
- an injury that could conventionally be treated with implantation of a short nerve graft
- nerve treatment initiated until 3 months after nerve injury
- signed informed consent
You may not qualify if:
- known allergy to chitosan and/or polyvinylpyrrolidone (PVP)
- 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
- complete amputation injury
- known pregnant or breast-feeding females
- disorders known leading to impaired wound healing (e.g. diabetes mellitus)
- skin diseases in the wound area
- impaired blood coagulation or bleeding disorders (e.g. because of regular intake of cumarin such as Marcumar)
- pathologic blood flow disorders (e.g. Morbus Raynaud)
- participated in another clinical investigation using an investigational new drug or device within 30 days prior to enrolment into this investigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medovent GmbHlead
Study Sites (4)
BG-Kliniken Bergmannstrost
Halle, Saxony-Anhalt, 06112, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
Unfallkrankenhaus Berlin
Berlin, 12683, Germany
BG Kliniken Hamburg gGmbH
Hamburg, 21033, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Siemers, PD Dr. med.
BG-Kliniken Bergmannstrost
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 1, 2015
Study Start
June 1, 2015
Primary Completion
May 31, 2018
Study Completion
May 31, 2018
Last Updated
June 18, 2018
Record last verified: 2018-06