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 Overview

• Status: Completed
• Conditions: Painful Digital Neuroma
• Intervention / Treatment: Device: Pedicled nerve flap

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Tangshan, Hebei, China, 063000
      • The Second Hospital of Tangshan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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; Other Names: Surgical flap; Island flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Second Hospital of Tangshan
• Collaborators: Chinese PLA General Hospital; The Second Hospital of Qinhuangdao
• Investigators: Study Chair: Gang Zhao, MD., The Second Hospital of Tangshan

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: September 11, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimated): September 13, 2012

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: June 1, 2012

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neurologic Manifestations; Neoplasms, Nerve Tissue; Nerve Sheath Neoplasms; Pain; Neuroma
• Other Study ID Numbers: HB-TS-120127; TSCHEN411206 (Other Identifier: Ethics Committee of HeBei Province)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No