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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Second Hospital of Tangshan
ClinicalTrials.gov Identifier:
NCT01559337
First received: March 19, 2012
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Sensory Restoration of the Reconstructed Finger Pulps
Cold Intolerance of the Reconstructed Finger
Pain of the Reconstructed Finger
 Procedure: Nerve transfer

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • static 2-point discrimination (2PD) test [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • self-administered Cold Intolerance Severity Score (CISS) questionnaire [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 17
Study Start Date: May 2007
Study Completion Date: January 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nerve repair
the dorsal branch of the proper digital nerve was used as a pedicle nerve for reconstructing PDN defects
 Procedure: Nerve transfer
the dorsal branch was used as a pedicle nerve for reconstructing PDN defects
Other Name: Local pedicle nerve transfer

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559337

Locations
China, Hebei
Ethetic Committee of Tangshan
Tangshan, Hebei, China, 063000
Sponsors and Collaborators
The Second Hospital of Tangshan
Investigators
Principal Investigator: Peifu Tang, MD. Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01559337     History of Changes
Other Study ID Numbers: CHEN-19750471
Study First Received: March 19, 2012
Last Updated: March 20, 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
nerve transfer
finger sensory reconstruction

ClinicalTrials.gov processed this record on May 23, 2013