Reconstruction of Digital Nerve Lesions With Muscle-in-Vein Conduits

• Sponsor: BG Trauma Center Tuebingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT04788030
• Collaborator: (none)
• Enrollment: 37
• Actual Duration (Months): 157

Study Details

Study Description

Brief Summary

Muscle-in-vein conduits (MVCs) provide an alternative for bridging digital nerve defects when tension-free suture is not possible. Low donor site morbidity and absence of additional costs are favorable advantages compared to autografts or conduits. 37 patients with 43 defects of proper palmar digital nerves were retrospectively enrolled. Primary repair by MVCs was performed in 22 cases while 21 underwent secondary reconstruction. Recovery of sensibility was assessed by static and moving two-point discrimination (2PDs, 2PDm) and Semmes-Weinstein monofilaments (SWM). Results were compared with contralateral side serving as intraindividual control. Outcome data were stratified according to international guidelines and evaluated for differences in terms of age, gap length, time of reconstruction and concomitant injuries.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Nerve Injury Upper Limb	Other: Nerve reconstruction

Study Design

• Study Type: Observational
• Actual Enrollment: 37 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Outcome After Reconstruction of 43 Digital Nerve Lesions With Muscle-in-Vein Conduits
• Actual Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Digital nerve reconstruction with muscle-in-vein conduits	Other: Nerve reconstruction; Nerve bridging with muscle-in-vein conduits

Outcome Measures

Primary Outcome Measures

1. Two-point discrimination [Six months after reconstruction or later]

2. Semmes-Weinstein-Monofilament test [Six months after reconstruction or later]

Secondary Outcome Measures

1. Age [Baseline]

2. Gap length [Baseline]

3. Time of reconstruction [Baseline]

4. Concomitant injuries [Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 72 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with reconstruction of digital nerves with muscle-in-vein conduits

Exclusion Criteria:

• Subtotal or total amputations

• pre-existing neurological disorders (e.g. polyneuropathy)

• symptoms of nerve entrapment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• BG Trauma Center Tuebingen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PD Dr. Theodora Wahler, Chief of the Department of Hand, Plastic and Aesthetic Surgery, medius Hospital Nürtingen, BG Trauma Center Tuebingen
• ClinicalTrials.gov Identifier: NCT04788030
• Other Study ID Numbers: 650/2018BO2-1
• First Posted: Mar 9, 2021
• Last Update Posted: Mar 9, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peripheral Nerve Injuries

Study Results

No Results Posted as of Mar 9, 2021