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Completed

NCT Number: NCT01528397

Reconstruction of Proper Digital Nerve Defects in the Thumb Using a Pedicled Nerve Graft

A proper digital nerve (PDN) defect in the thumb can produce partial or complete sensory loss which can result in functional disability. This article reports the treatment of the thumb PDN defect using a pedicled nerve graft harvested from the dorsal branch of the PDN. Fourteen patients with the thumb PDN defect underwent a new surgical procedure in which the pedicled nerve graft was used to bridge nerve defect. For comparison, the investigators also collected a consecutive series of 21 patients with thumb PDN defects treated using a nonvascularized sural nerve graft. This study was designed to evaluate the efficacy of pedicled nerve grafting for PDN defects in the thumb.

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Key information

Conditions

Nerve Injury

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

At final follow-up, the investigators measured the sensibility of the thumb pulps and the donor sites using the Semmes-Weinstein monofilament test and static 2-point discrimination (2PD) test. The test points were at the centers of the radial and ulnar portions of the thumb pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • thumb PDN defects between the middle of the distal phalanx and the metacarpophalangeal joint;
  • PDN defects of single or both sides;
  • PDN defects 1-4 cm in length.

Exclusion criteria

  • injury to the course of the pedicle or the donor sites;
  • PDN defects less than 1 cm or longer than 4 cm;
  • no Doppler sound at the location of the second dorsal metacarpal artery (SDMA).

Treatment and study plan

pedicled nerve graft

Procedure

A pedicled nerve graft harvested from the dorsal branch of the PDN can be used for reconstruction of such defects. The graft is based on the second dorsal metacarpal artery.

Other names: Vascularized nerve graft

Primary outcomes

  1. static 2-point discrimination (2PD) test

    Time frame: 22 months

    The test points were at the centers of the radial and ulnar portions of the thumb pulp and the donor sites separately. Each area was tested 3 times with a Dellon-Mackinnon discriminator. Two out of 3 correct answers were considered proof of perception before proceeding to another lower value.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Tangshan

Other

Collaborators

  • Chinese PLA General Hospital

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Feb 8, 2012
Registry last updated
Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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