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Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01684839
Recruitment Status : Completed
First Posted : September 13, 2012
Results First Posted : October 23, 2013
Last Update Posted : October 23, 2013
Sponsor:
Collaborators:
Chinese PLA General Hospital
The Second Hospital of Qinhuangdao
Information provided by (Responsible Party):
The Second Hospital of Tangshan

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Painful Digital Neuroma Device: Pedicled nerve flap Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : May 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2012

Arm Intervention/treatment
new surgical treatment
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Device: Pedicled nerve flap
This nerve flap is a vascularized nerve graft
Other Names:
  • Surgical flap
  • Island flap




Primary Outcome Measures :
  1. Static 2-point Discrimination Test [ Time Frame: 20-26 months postoperatively ]
    The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.


Secondary Outcome Measures :
  1. Cold Intolerance Severity Score (CISS) Questionnaire [ Time Frame: 20-26 months postoperatively ]
    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.


Other Outcome Measures:
  1. Tinel's Sign [ Time Frame: 20-26 months postoperatively ]
    Tinel's sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma



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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684839


Locations
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China, Hebei
The Second Hospital of Tangshan
Tangshan, Hebei, China, 063000
Sponsors and Collaborators
The Second Hospital of Tangshan
Chinese PLA General Hospital
The Second Hospital of Qinhuangdao
Investigators
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Study Chair: Gang Zhao, MD. The Second Hospital of Tangshan
Publications of Results:
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Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01684839    
Other Study ID Numbers: HB-TS-120127
TSCHEN411206 ( Other Identifier: Ethics Committee of HeBei Province )
First Posted: September 13, 2012    Key Record Dates
Results First Posted: October 23, 2013
Last Update Posted: October 23, 2013
Last Verified: June 2012
Keywords provided by The Second Hospital of Tangshan:
Painful digital neuroma
nerve defect
dorsal branch of the digital nerve
digital nerve
pedicled nerve flap
Pain Disorder Associated with Psychological and Physical Factors
Additional relevant MeSH terms:
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Neuroma
Pain
Neurologic Manifestations
Signs and Symptoms
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms