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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Painful Digital Neuroma
Intervention Device: Pedicled nerve flap
Enrollment 9
Recruitment Details Nine patients were included in the study. These patients were treated with the pedicled nerve flap. The type of location was medical clinic.
Pre-assignment Details No wash out, run-in or transition happened in the study.
Arm/Group Title New Surgical Treatment
Hide Arm/Group Description Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title New Surgical Treatment
Hide Arm/Group Description Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
31.4  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
2
  22.2%
Male
7
  77.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 9 participants
9
1.Primary Outcome
Title Static 2-point Discrimination Test
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title New Surgical Treatment
Hide Arm/Group Description:
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: mm
7.3  (2.0)
2.Secondary Outcome
Title Cold Intolerance Severity Score (CISS) Questionnaire
Hide 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
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Tinel's Sign
Hide 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
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title New Surgical Treatment
Hide Arm/Group Description Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
All-Cause Mortality
New Surgical Treatment
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
New Surgical Treatment
Affected / at Risk (%)
Total   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
New Surgical Treatment
Affected / at Risk (%)
Total   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Chao Chen
Organization: The Second Hospital of Tangshan
Phone: 86-13700350471
EMail: ts_chenchao@163.com
Layout table for additonal information
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 Submitted: September 11, 2012
First Posted: September 13, 2012
Results First Submitted: June 3, 2013
Results First Posted: October 23, 2013
Last Update Posted: October 23, 2013