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临床试验/NCT01684839
NCT01684839已完成不适用

Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap

The Second Hospital of Tangshan1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Static 2-point Discrimination Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Static 2-point Discrimination Test

时间窗: 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.

次要结局

  • Cold Intolerance Severity Score (CISS) Questionnaire(20-26 months postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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