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Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap

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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

Tracking Information
First Submitted Date  ICMJE September 11, 2012
First Posted Date  ICMJE September 13, 2012
Results First Submitted Date  ICMJE June 3, 2013
Results First Posted Date  ICMJE October 23, 2013
Last Update Posted Date October 23, 2013
Study Start Date  ICMJE May 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2012)
Static 2-point Discrimination Test [ Time Frame: 20-26 months postoperatively ]
The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side) and the donor site separately. 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) [11].
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2012)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
Official Title  ICMJE Not Provided
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Painful Digital Neuroma
Intervention  ICMJE Device: Pedicled nerve flap
This nerve flap is a vascularized nerve graft
Other Names:
  • Surgical flap
  • Island flap
Study Arms  ICMJE new surgical treatment
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Intervention: Device: Pedicled nerve flap
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2012)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01684839
Other Study ID Numbers  ICMJE HB-TS-120127
TSCHEN411206 ( Other Identifier: Ethics Committee of HeBei Province )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Second Hospital of Tangshan
Study Sponsor  ICMJE The Second Hospital of Tangshan
Collaborators  ICMJE
  • Chinese PLA General Hospital
  • The Second Hospital of Qinhuangdao
Investigators  ICMJE
Study Chair: Gang Zhao, MD. The Second Hospital of Tangshan
PRS Account The Second Hospital of Tangshan
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP