Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
- Static 2-point Discrimination Test [ Time Frame: 20-26 months postoperatively ] [ Designated as safety issue: No ]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.
- Cold Intolerance Severity Score (CISS) Questionnaire [ Time Frame: 20-26 months postoperatively ] [ Designated as safety issue: No ]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.
- Tinel's Sign [ Time Frame: 20-26 months postoperatively ] [ Designated as safety issue: No ]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
|Study Start Date:||May 2007|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
new surgical treatment
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Device: Pedicled nerve flap
This nerve flap is a vascularized nerve graft
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684839
|The Second Hospital of Tangshan|
|Tangshan, Hebei, China, 063000|
|Study Chair:||Gang Zhao, MD.||The Second Hospital of Tangshan|