N/A
N=9
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
Painful Digital Neuroma
Bottom Line
View on ClinicalTrials.gov: NCT01684839 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Static 2-point Discrimination Test — 7.3 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pedicled nerve flap (Device)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- The Second Hospital of Tangshan
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Static 2-point Discrimination Test |
7.3 | — |
| SECONDARY Cold Intolerance Severity Score (CISS) Questionnaire |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01684839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.