Nerve Transfer for Finger Sensory Reconstruction With Dorsal Branch of the Digital Nerve

March 20, 2012 updated by: The Second Hospital of Tangshan
A proper digital nerve (PDN) defect causes partial or complete sensory loss of the finger pulp, which results in functional disability.The dorsal branch of the PDN can be transferred for reconstruction of such nerve defects.In this study, the investigators modified the Lesavoy et al' technique and evaluated the efficacy of dorsal sensory branch transfer for PDN defects. For comparison, the investigators collected a consecutive series of 32 patients with finger PDN defects treated using a traditional sural nerve graft from February 2005 to October 2008.

Study Overview

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hebei
      • Tangshan, Hebei, China, 063000
        • Ethetic Committee of Tangshan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Finger PDN defects proximal to the proximal interphalangeal joint
  2. Single or two PDN defects
  3. PDN defects longer than 1 cm.

Exclusion Criteria:

  1. PDN defects less than 1 cm
  2. Concomitant injuries to the multiple dorsal sensory branches that preclude their use as nerve donor sites
  3. Thumb PDN defects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Nerve repair
the dorsal branch of the proper digital nerve was used as a pedicle nerve for reconstructing PDN defects
the dorsal branch was used as a pedicle nerve for reconstructing PDN defects
Other Names:
  • Local pedicle nerve transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
static 2-point discrimination (2PD) test
Time Frame: 26 months
At final follow-up, we measured the sensibility of the pulps and the donor sites using the static 2-point discrimination (2PD) test. The test points were at the center of the radial or ulnar portion of the 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.
26 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-administered Cold Intolerance Severity Score (CISS) questionnaire
Time Frame: 26 months
The maximum score was 100 and was grouped into 4 ranges (0-25, 26-50, 51-75, and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.
26 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Peifu Tang, MD., Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 20, 2012

First Posted (ESTIMATE)

March 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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