Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap

This study has been completed.
Sponsor:
Collaborators:
Chinese PLA General Hospital
The Second Hospital of Qinhuangdao
Information provided by (Responsible Party):
The Second Hospital of Tangshan
ClinicalTrials.gov Identifier:
NCT01684839
First received: September 11, 2012
Last updated: August 19, 2013
Last verified: June 2012
  Purpose

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 Intervention
Painful Digital Neuroma
Device: Pedicled nerve flap

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Further study details as provided by The Second Hospital of Tangshan:

Primary Outcome Measures:
  • Static 2-point Discrimination Test [ Time Frame: 20-26 months postoperatively ] [ Designated as safety issue: No ]
    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:
  • Cold Intolerance Severity Score (CISS) Questionnaire [ Time Frame: 20-26 months postoperatively ] [ Designated as safety issue: No ]
    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:
  • Tinel's Sign [ Time Frame: 20-26 months postoperatively ] [ Designated as safety issue: No ]
    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


Enrollment: 9
Study Start Date: May 2007
Study Completion Date: March 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684839

Locations
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
Study Chair: Gang Zhao, MD. The Second Hospital of Tangshan
  More Information

Publications:
Responsible Party: The Second Hospital of Tangshan
ClinicalTrials.gov Identifier: NCT01684839     History of Changes
Other Study ID Numbers: HB-TS-120127, TSCHEN411206
Study First Received: September 11, 2012
Results First Received: June 3, 2013
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration
China: Ethics Committee

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:
Neuroma
Pain
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014