NCT01528397

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
Last Updated

February 8, 2012

Status Verified

January 1, 2012

Enrollment Period

4.3 years

First QC Date

January 31, 2012

Last Update Submit

February 7, 2012

Conditions

Keywords

defectdorsal branch of the proper digital nerveproper digital nervesecond dorsal metacarpal arterypedicled nerve graft.

Outcome Measures

Primary Outcomes (1)

  • 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.

    22 months

Interventions

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.

Also known as: Vascularized nerve graft

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chen C, Tang P, Zhang X. Reconstruction of proper digital nerve defects in the thumb using a pedicle nerve graft. Plast Reconstr Surg. 2012 Nov;130(5):1089-1097. doi: 10.1097/PRS.0b013e318267d56b.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 8, 2012

Study Start

May 1, 2005

Primary Completion

September 1, 2009

Study Completion

May 1, 2010

Last Updated

February 8, 2012

Record last verified: 2012-01