Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
Primary Purpose
Painful Digital Neuroma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pedicled nerve flap
Sponsored by
About this trial
This is an interventional treatment trial for Painful Digital Neuroma focused on measuring Painful digital neuroma, nerve defect, dorsal branch of the digital nerve, digital nerve, pedicled nerve flap, Pain Disorder Associated with Psychological and Physical Factors
Eligibility 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
Sites / Locations
- The Second Hospital of Tangshan
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
new surgical treatment
Arm Description
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Outcomes
Primary Outcome Measures
Static 2-point Discrimination Test
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
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.
Full Information
NCT ID
NCT01684839
First Posted
September 11, 2012
Last Updated
August 19, 2013
Sponsor
The Second Hospital of Tangshan
Collaborators
Chinese PLA General Hospital, The Second Hospital of Qinhuangdao
1. Study Identification
Unique Protocol Identification Number
NCT01684839
Brief Title
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Tangshan
Collaborators
Chinese PLA General Hospital, The Second Hospital of Qinhuangdao
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Digital Neuroma
Keywords
Painful digital neuroma, nerve defect, dorsal branch of the digital nerve, digital nerve, pedicled nerve flap, Pain Disorder Associated with Psychological and Physical Factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
new surgical treatment
Arm Type
Other
Arm Description
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Intervention Type
Device
Intervention Name(s)
Pedicled nerve flap
Other Intervention Name(s)
Surgical flap, Island flap
Intervention Description
This nerve flap is a vascularized nerve graft
Primary Outcome Measure Information:
Title
Static 2-point Discrimination Test
Description
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.
Time Frame
20-26 months postoperatively
Secondary Outcome Measure Information:
Title
Cold Intolerance Severity Score (CISS) Questionnaire
Description
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.
Time Frame
20-26 months postoperatively
Other Pre-specified Outcome Measures:
Title
Tinel's Sign
Description
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
Time Frame
20-26 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Zhao, MD.
Organizational Affiliation
The Second Hospital of Tangshan
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Hospital of Tangshan
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
1262369
Citation
Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73.
Results Reference
result
PubMed Identifier
1032972
Citation
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.
Results Reference
result
Learn more about this trial
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
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