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

NCT04788030 | Completed

• 1 other identifier: 650/2018BO2-1
• Study Type: observational
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Nerve Injury Upper Limb

Outcome Measures

Primary Outcomes (2)

• Two-point discrimination

  Six months after reconstruction or later

• Semmes-Weinstein-Monofilament test

  Six months after reconstruction or later

Secondary Outcomes (4)

• Age

  Baseline

• Gap length

  Baseline

• Time of reconstruction

  Baseline

• Concomitant injuries

  Baseline

Study Arms (1)

Digital nerve reconstruction with muscle-in-vein conduits

Other: Nerve reconstruction

Interventions

Nerve reconstruction OTHER

Nerve bridging with muscle-in-vein conduits

Digital nerve reconstruction with muscle-in-vein conduits

Eligibility Criteria

• Age: 6 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The mean age of all patients was 38.0 years (SD 18.4, range 6-72). All patients aged younger than 18 years were males whereas patients older than 60 years tend to be females.

You may qualify if:

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

You may not qualify if:

• Subtotal or total amputations
• pre-existing neurological disorders (e.g. polyneuropathy)
• symptoms of nerve entrapment

Sponsors & Collaborators

• BG Trauma Center Tuebingen: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Department of Hand, Plastic and Aesthetic Surgery, medius Hospital Nürtingen

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 9, 2021
• Study Start: January 1, 2008
• Primary Completion: December 31, 2017
• Study Completion: January 31, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03