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临床试验/NCT03930537
NCT03930537已完成不适用

DIfference of Femoral Intramedullar Pressure After Implantation of Cemented Versus Non-cemented Femoral Component of Hip Prothesis

University Clinical Centre of Kosova2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Change of pressure in femoral intramedullary canal after implantation of femoral component

研究概览

简要总结

It is well known that the changes in intramedullary canal during orthopedic surgeries can cause variuos complication. The change of femoral intramedullary pressure after implantation of hip replacement and its possible complications are not well studied and the investigators are aiming to give more answer to this issue.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient undergoing hip replacement with cemented and non-cemented femoral component

排除标准

  • Patient with periprosthetic fractures
  • Patient with hip replacement revision

结局指标

主要结局

Change of pressure in femoral intramedullary canal after implantation of femoral component

时间窗: The femoral intramedullary pressure will be measured before the cut of femoral neck and continuously during first 10 minutes after the implantation of cemented femoral component

The pressure in intramedullary canal will be measured with customized device

次要结局

  • Difference of arterial pressure after implantation of femoral component(The changes will be measured before implantation and during first 10 minutes after implantation)
  • Difference of changes of Leukocyte formula after implantation of femoral component(The blood will be taken from patience 1 hour before and POD1)
  • Difference of changes of Histamine after implantation of femoral component(The blood will be taken from patience 1 hour before and POD1)
  • Difference of SpCO after implantation of femoral component(The changes will be measured before implantation and during first 10 minutes after implantation)
  • Difference of changes of CRP after implantation of femoral component(The blood will be taken from patience 1 hour before and POD1)
  • Difference of SpO2 after implantation of femoral component(The changes will be measured before implantation and during first 10 minutes after implantation)

研究者

发起方
University Clinical Centre of Kosova
申办方类型
Other
责任方
Principal Investigator
主要研究者

Skender Ukaj

Specialist of Orthopaedics and Trauma

University Clinical Centre of Kosova

研究点 (2)

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