Clinical trial NCT01684839: Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Painful Digital Neuroma
Keywords: Painful digital neuroma
nerve defect
dorsal branch of the digital nerve
digital nerve
pedicled nerve flap
Pain Disorder Associated with Psychological and Physical Factors
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: The Second Hospital of Qinhuangdao
First posted: 2012-09-13
Enrollment: 9
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Static 2-point Discrimination Test
timeFrame: 20-26 months postoperatively
Secondary outcomes:
measure: Cold Intolerance Severity Score (CISS) Questionnaire
timeFrame: 20-26 months postoperatively
Other outcomes:
measure: Tinel's Sign
timeFrame: 20-26 months postoperatively
Locations:
city: Tangshan
country: China
facility: The Second Hospital of Tangshan
state: Hebei
Study officials:
affiliation: The Second Hospital of Tangshan
name: Gang Zhao, MD.
role: STUDY_CHAIR
References:
citation: Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73.
citation: 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.