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

Outcome After Reconstruction of 43 Digital Nerve Lesions With Muscle-in-Vein Conduits

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Nerve Injury Upper Limb
• Intervention / Treatment: Other: Nerve reconstruction

• Study Type: Observational
• Enrollment (Actual): 37

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 72 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Two-point discrimination	Six months after reconstruction or later
Semmes-Weinstein-Monofilament test	Six months after reconstruction or later

Secondary Outcome Measures

Outcome Measure	Time Frame
Age	Baseline
Gap length	Baseline
Time of reconstruction	Baseline
Concomitant injuries	Baseline

Collaborators and Investigators

• Sponsor: BG Trauma Center Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries
• Other Study ID Numbers: 650/2018BO2-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No