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临床试验/NCT01116362
NCT01116362已完成2 期

Study of Surgical Methods for Repair of Clean Transections in Peripheral Nerve Injuries

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2008年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
46
试验地点
1
主要终点
motor function

研究概览

简要总结

The purpose of this study is to determine which surgical approach is better for clean transection injury in peripheral nerves in outcomes.

详细描述

Treatment of injuries to major nerve trunks in the hand and upper extremity remains a major and challenging reconstructive problem. Our goal was to compare primary versus secondary repair of median and\or ulnar nerve by electrodiagnostic assessment and clinical examination.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •patients with confirmed clean transection injury between shoulder and wrist

排除标准

  • •crush injuries

研究组 & 干预措施

secondary repair

Other

secondary closure beyond the first week.the nerve was conducted to repair as end to end (epi-epineurium, epi-epineurium) anastomosis. This was performed following the repair of present tendons and muscle injuries.

干预措施: secondary repair (Procedure)

primary repair

Other

during first days,the nerve was conducted to repair as end to end (epi-epineurium, epi-epineurium) anastomosis. This was performed following the repair of present tendons and muscle injuries.

干预措施: primary repair (Procedure)

结局指标

主要结局

motor function

时间窗: at 18 months post-operatively

identification of motor level were done based on British Medical Research Council guided.The abductor pollicis brevis (APB) was used for the median nerve and the abductor digiti minimi (ADM) for the ulnar nerve. as follows: 0, M0, M1 and M2; 1, M3; 2, M4.

次要结局

  • sensory recovery(at 18 months post-operatively)
  • nerve conduction velocity(at 18 months post-operatively)
  • electromyography(at 18 months post-operatively)

研究者

申办方类型
Other

研究点 (1)

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