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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
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.
BG-Kliniken Bergmannstrost
Halle, Saxony-Anhalt, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Unfallkrankenhaus Berlin
Berlin, Germany
BG Kliniken Hamburg gGmbH
Hamburg, Germany
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
Time frame: Primary outcome analysis will be performed from the clinical evaluations at 12 months post-surgery
Static 2-point discrimination (2-PD)
see description above
Time frame: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Moving 2-PD
A moving stimulus of either one or two points is assessed using a small tool with prongs at fixed spacing's from 2 to 15 mm. One or two points will be moved randomly in a longitudinal direction from proximal to distal of all fingers. Grades/scores: see Static 2-PD
Time frame: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Semmes-Weinstein Monofilament
The 5 kit monofilaments will be used. A monofilament is pressed against the skin at specific locations (see protocol) starting with the thinnest filament (i.e. 2.83) and then, depending on the response, thicker filaments are applied until the subject feels the pressure. Grades/scores: 0 = not testable 1. = filament 6.65, perception of deep pressure 2. = filament 4.56, no protective sensation 3. = filament 4.31, diminished protective sensation 4. = filament 3.61, diminished perception of light touch 5. = filament 2.83, normal perception of light touch
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Time frame: Follow-up examinations 3, 6, 12 and 18 months post-surgery
Subject's estimation of cold intolerance and hyperesthesia
The examiner will stroke the dysfuntional area and question the subject about cold intolerance and hypersensitivity. Grades/scores: 0 = Hinders function 1. = Disturbing 2. = Moderate 3. = None/minor
Time frame: Follow-up examinations 3, 6, 12 and 18 months post-surgery
Hoffmann-Tinel-Test
The test is performed by lightly tapping over the nerve to elicit a sensation of tingling in the distribution of the nerve. The distance of the sensation from the distal end of the implant will be determined.
Time frame: Follow-up examinations 3, 6, 12 and 18 months post-surgery
post-operative complications
There will be evaluations of common post-operative complications associated with peripheral nerve repair surgery, i.e. painful neuroma formation, assessed by pain on percussion, allodynia, and dysaesthesia (pain and/or numbness).
Time frame: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery