NCT01559337

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
Last Updated

March 21, 2012

Status Verified

March 1, 2012

Enrollment Period

2.1 years

First QC Date

March 19, 2012

Last Update Submit

March 20, 2012

Conditions

Keywords

defectdorsal branch of the proper digital nerveproper digital nervenerve transferfinger sensory reconstruction

Outcome Measures

Primary Outcomes (1)

  • static 2-point discrimination (2PD) test

    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 Outcomes (1)

  • self-administered Cold Intolerance Severity Score (CISS) questionnaire

    26 months

Study Arms (1)

Nerve repair

OTHER

the dorsal branch of the proper digital nerve was used as a pedicle nerve for reconstructing PDN defects

Procedure: Nerve transfer

Interventions

the dorsal branch was used as a pedicle nerve for reconstructing PDN defects

Also known as: Local pedicle nerve transfer
Nerve repair

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethetic Committee of Tangshan

Tangshan, Hebei, 063000, China

Location

MeSH Terms

Interventions

Nerve Transfer

Intervention Hierarchy (Ancestors)

Neurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Peifu Tang, MD.

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

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

March 19, 2012

First Posted

March 21, 2012

Study Start

May 1, 2007

Primary Completion

June 1, 2009

Study Completion

January 1, 2012

Last Updated

March 21, 2012

Record last verified: 2012-03

Locations