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

This study has been completed.
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
The Second Hospital of Tangshan
ClinicalTrials.gov Identifier:
NCT01528397
First received: January 31, 2012
Last updated: February 7, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Nerve Injury
Procedure: pedicled nerve graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Second Hospital of Tangshan:

Primary Outcome Measures:
  • static 2-point discrimination (2PD) test [ Time Frame: 22 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 14
Study Start Date: May 2005
Study Completion Date: May 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: pedicled nerve graft
    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 Name: Vascularized nerve graft
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. injury to the course of the pedicle or the donor sites;
  2. PDN defects less than 1 cm or longer than 4 cm;
  3. no Doppler sound at the location of the second dorsal metacarpal artery (SDMA).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by The Second Hospital of Tangshan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01528397     History of Changes
Other Study ID Numbers: TSChen3885
Study First Received: January 31, 2012
Last Updated: February 7, 2012
Health Authority: China: Ethics Committee

Keywords provided by The Second Hospital of Tangshan:
defect
dorsal branch of the proper digital nerve
proper digital nerve
second dorsal metacarpal artery
pedicled nerve graft.

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 23, 2014