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临床试验/NCT05871866
NCT05871866Unknown不适用

The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures

Sohag University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
union

研究概览

简要总结

Pelvic fractures are common presentations to major trauma centers and are associated with significant morbidity in polytrauma patients. Traditional open reduction and internal fixation is associated with a high incidence of surgical morbidity, while external fixators, used for both temporary stabilisation and as definitive management, have a complication rate of up to 62% [4], with poor patient tolerance, pin site infection and aseptic loosening the more commonly documented complications in the literature.

Minimally invasive techniques have become more popular recently in the management of pelvic injuries due to their lower incidence of surgical morbidity. The application of a pelvic internal fixator (INFIX) has been presented as a comparable alternative to external fixation of anterior pelvic ring injuries.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who had APC-II
  • •Patients who had APC-III
  • •Patients who had LC - II
  • •Patients who had LC -III

排除标准

  • •Patients who had immature skeletons or medical contraindications such as combined neurovascular injuries and uncontrolled medical diseases.
  • •Open fractures.
  • •Stable pelvic ring fractures.
  • •Patients who had combined acetabular fractures
  • •Patients who had a hernia or previous lower abdominal surgery.
  • •Pregnancy.

结局指标

主要结局

union

时间窗: 1 yea

radiological

advantages using INFIX

时间窗: 6 months

good patient tolerance

次要结局

未报告次要终点

研究者

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

Mohamed Essam Ahmed

Assistant lecturer

Sohag University

研究点 (1)

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