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| ID | Type | Description | Link |
|---|---|---|---|
| TSCHEN411206 | Other Identifier | Ethics Committee of HeBei Province |
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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| The Second Hospital of Qinhuangdao | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new surgical treatment | Other | Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedicled nerve flap | Device | This nerve flap is a vascularized nerve graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20-26 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20-26 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Tinel's Sign | 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 | 20-26 months postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Zhao, MD. | The Second Hospital of Tangshan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Tangshan | Tangshan | Hebei | 063000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1262369 | Result | Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73. | |
| 1032972 | Result | 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. |
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No wash out, run-in or transition happened in the study.
Nine patients were included in the study. These patients were treated with the pedicled nerve flap. The type of location was medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | New Surgical Treatment | Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | New Surgical Treatment | Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm | 20-26 months postoperatively |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New Surgical Treatment | Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chao Chen | The Second Hospital of Tangshan | 86-13700350471 | ts_chenchao@163.com |
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| ID | Term |
|---|---|
| D013524 | Surgical Flaps |
| ID | Term |
|---|---|
| D019738 | Surgically-Created Structures |
| D004864 | Equipment and Supplies |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Not Posted | 20-26 months postoperatively | Participants |
| Other Pre-specified | Tinel's Sign | 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 | Not Posted | 20-26 months postoperatively | Participants |
| 0 |
| 9 |
| 0 |
| 9 |
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