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

Peripheral Nerve Injury Upper Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04788030
• Other study ID #: 650/2018BO2-1
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: January 31, 2021

Study information

• Verified date: March 2021
• Source: BG Trauma Center Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nerve Injuries
• Peripheral Nerve Injury Upper Limb

Intervention

Other:
• Nerve reconstruction
Nerve bridging with muscle-in-vein conduits

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BG Trauma Center Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-point discrimination		Six months after reconstruction or later
Primary	Semmes-Weinstein-Monofilament test		Six months after reconstruction or later
Secondary	Age		Baseline
Secondary	Gap length		Baseline
Secondary	Time of reconstruction		Baseline
Secondary	Concomitant injuries		Baseline