Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap

NCT01684839 | Completed Results

• 2 other identifiers: HB-TS-120127TSCHEN411206
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Cold Intolerance Severity Score (CISS) Questionnaire

  20-26 months postoperatively

Other Outcomes (1)

• Tinel's Sign

  20-26 months postoperatively

Study Arms (1)

new surgical treatment

OTHER

Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.

Device: Pedicled nerve flap

Interventions

Pedicled nerve flap DEVICE

This nerve flap is a vascularized nerve graft

Also known as: Surgical flap, Island flap

new surgical treatment

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Tangshan: lead
• Chinese PLA General Hospital: collaborator
• The Second Hospital of Qinhuangdao: collaborator

Study Sites (1)

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

Location

Related Publications (2)

• Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73.

  PMID: 1262369 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.

  PMID: 1032972 RESULT

MeSH Terms

Interventions

Surgical Flaps

Intervention Hierarchy (Ancestors)

Surgically-Created Structures; Equipment and Supplies

Results Point of Contact

• Title: Dr. Chao Chen
• Organization: The Second Hospital of Tangshan

ts_chenchao@163.com

86-13700350471

Study Officials

• Gang Zhao, MD.

  The Second Hospital of Tangshan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: May 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2012
• Last Updated: February 15, 2024
• Results First Posted: October 23, 2013

Record last verified: 2012-06

Locations

CN (1)