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
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Tracking Information | ||||
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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 |
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.
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Original Primary Outcome Measures ICMJE |
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].
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures |
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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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. |
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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 |
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Condition ICMJE | Painful Digital Neuroma | |||
Intervention ICMJE | Device: Pedicled nerve flap
This nerve flap is a vascularized nerve graft
Other Names:
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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
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Publications * | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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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 |
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Investigators ICMJE |
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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 |