Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap

NCT ID: NCT01684839

Last Updated: 2024-02-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2012-03-31

Brief Summary

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Neuroma excision and digital nerve reconstruction remain the best option for the treatment of Painful Digital Neuroma (PDN). When the distal nerve end is preserved, conventional nonvascularized nerve grafting is the primary option to bridge the defect. The investigators hypothesize the pedicled nerve flap taken from the dorsal branch of the homolateral digital nerve is better than conventional methods for reconstruction of the digital nerve defect after painful neuroma resection.

This study reports treatment of painful digital neuroma using a pedicled nerve flap taken from the dorsal branch of homolateral digital nerve. From May 2007 to March 2010, the patients had previous nerve injuries with or without nerve repair. The mechanisms of injury include sharp cut, avulsion and crush. The defects were between the middle of the distal phalanx and the palmar digital crease.

Detailed Description

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Our selection criteria in this study included a patient with PDN in a scarred wound bed or poor coverage, a PDN located between the middle of the distal phalanx and the palmar digital crease, and a defect of the digital nerve after neuroma resection equal to or less than 3 cm in length. The exclusion criteria included a PDN in healthy soft tissue, a digital nerve defect longer than 3 cm, injury to the course of the pedicle or the donor nerve, and a thumb neuroma. A finger with a small distal end of the digital nerve was also excluded, because neurorrhaphy was extremely difficult in this situation.

Conditions

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Painful Digital Neuroma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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new surgical treatment

Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.

Group Type OTHER

Pedicled nerve flap

Intervention Type DEVICE

This nerve flap is a vascularized nerve graft

Interventions

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Pedicled nerve flap

This nerve flap is a vascularized nerve graft

Intervention Type DEVICE

Other Intervention Names

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Surgical flap Island flap

Eligibility Criteria

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Inclusion Criteria

* a patient with PDN in a scarred wound bed or poor coverage
* a PDN located between the middle of the distal phalanx and the palmar digital crease
* a defect of the digital nerve after neuroma resection equal to or less than 3 cm in length

Exclusion Criteria

* a PDN in healthy soft tissue
* a digital nerve defect longer than 3 cm
* injury to the course of the pedicle or the donor nerve
* a thumb neuroma
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Qinhuangdao

OTHER

Sponsor Role collaborator

The Second Hospital of Tangshan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gang Zhao, MD.

Role: STUDY_CHAIR

The Second Hospital of Tangshan

Locations

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The Second Hospital of Tangshan

Tangshan, Hebei, China

Site Status

Countries

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China

References

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Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73.

Reference Type RESULT
PMID: 1262369 (View on PubMed)

Tupper JW, Booth DM. Treatment of painful neuromas of sensory nerves in the hand: a comparison of traditional and newer methods. J Hand Surg Am. 1976 Sep;1(2):144-51. doi: 10.1016/s0363-5023(76)80008-1.

Reference Type RESULT
PMID: 1032972 (View on PubMed)

Other Identifiers

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TSCHEN411206

Identifier Type: OTHER

Identifier Source: secondary_id

HB-TS-120127

Identifier Type: -

Identifier Source: org_study_id

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