Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap

• ClinicalTrials.gov Identifier: NCT01684839
• Recruitment Status: Completed
• First Posted: September 13, 2012
• Results First Posted: October 23, 2013
• Last Update Posted: October 23, 2013
• Sponsor: The Second Hospital of Tangshan
• Collaborators: Chinese PLA General Hospital; The Second Hospital of Qinhuangdao
• Information provided by (Responsible Party): The Second Hospital of Tangshan

Tracking Information

• First Submitted Date: September 11, 2012
• First Posted Date: September 13, 2012
• Results First Submitted Date: June 3, 2013
• Results First Posted Date: October 23, 2013
• Last Update Posted Date: October 23, 2013
• Study Start Date: May 2007
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2013)

Static 2-point Discrimination Test [ Time Frame: 20-26 months postoperatively ]

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.

Original Primary Outcome Measures (submitted: September 12, 2012)

Static 2-point Discrimination Test [ Time Frame: 20-26 months postoperatively ]

The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side) and the donor site separately. 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) [11].

Current Secondary Outcome Measures (submitted: September 12, 2012)

Cold Intolerance Severity Score (CISS) Questionnaire [ Time Frame: 20-26 months postoperatively ]

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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: September 12, 2012)

Tinel's Sign [ Time Frame: 20-26 months postoperatively ]

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
• Official Title: Not Provided

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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Painful Digital Neuroma

Intervention

Device: Pedicled nerve flap

This nerve flap is a vascularized nerve graft

Other Names:

• Surgical flap
• Island flap

Study Arms

new surgical treatment

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

Intervention: Device: Pedicled nerve flap

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 12, 2012): 9
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2012
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 55 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01684839
• Other Study ID Numbers: HB-TS-120127; TSCHEN411206 ( Other Identifier: Ethics Committee of HeBei Province )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: The Second Hospital of Tangshan
• Study 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

• PRS Account: The Second Hospital of Tangshan
• Verification Date: June 2012