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临床试验/NCT04089124
NCT04089124已完成不适用

Randomized Controlled Trial to Compare the Outcomes Of Zone II Flexor Tendon Repair of the Hand Under General Anesthesia Versus Wide Awake Local Anesthesia No Tourniquet

Assiut University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
range of motions using Jamar finger goniometer

研究概览

简要总结

Comparison between results of repair of cut flexor zone II under General anesthesia and Walant

详细描述

Cut Flexor is common injury ,has unique characters as they cannot heal without surgical treatment, unique anatomy of the tendons running through flexor tendon sheaths to function and postoperative management &mobilization to prevent adhesions and improve gliding but risk of rupture.

The hand is divided into five zones (Verdan's). Zone II is described by Bunnel as "No Man's Land" historically back to 14th century (area outside London used for executions) because it was previously believed that primary repair should not be done in this zone. After understanding of flexor tendon anatomy, biomechanics , and healing new techniques of surgery and anesthesia repair is possible with good results.

General anesthesia has been the standard technique for along time. wide awake local anesthesia no tourniquet. (WALANT),using safe drugs lidocaine for anesthesia and epinephrine for hemostasis, the investigators can do operations while patient is awake.

WALANT has been recommended by some surgeons to be the next standard for repair of zone 2 injuries .

This techniques has a lot of Advantages in repair zone II as 1) intraoperative testing of the flexor repair by active movement to exclude any gap. and lets the surgeon see that the repair fits through the pulleys with active movement.

研究设计

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

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Acute zone II flexor tendon injuries of the hand in both genders in medial four fingers.
  • •Cooperative patients aged between 16-60 years.
  • •Sharp mechanism of injury
  • •Single level injury

排除标准

  • •Age less than sixteen years old or more than sixty years old .
  • •Associated fractures close to the tendon injury.
  • •Vascular injury requiring revascularization
  • •Multiple level injury
  • •Combined flexor and extensor laceration
  • •Insufficient skin and soft tissue coverage
  • •Tendon substance loss

研究组 & 干预措施

repair using Walant

Other

Surgery repair zone II under WALANT

干预措施: surgery of zone II cut flexor repair (Procedure)

repair using General anesthesia ( control group)

Other

Surgery repair zone II under GA

干预措施: surgery of zone II cut flexor repair (Procedure)

结局指标

主要结局

range of motions using Jamar finger goniometer

时间窗: baseline (2 weeks, 1.5 months , 3 months , 4.5 months and 6 months .)

The functions of treated fingers were calculated using original Strickland and Glogovac criteria

次要结局

  • complications(baseline)
  • Healing vs failure of repair(baseline)
  • DASH score using DASH questionnaire(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mina S. Fekry

Demonstrator

Assiut University

研究点 (1)

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