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临床试验/NCT01042132
NCT01042132已完成不适用

Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture

Ullevaal University Hospital2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2003年5月1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
17
试验地点
2
主要终点
cardiopulmonary alterations

研究概览

简要总结

To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).

详细描述

To what extent the cardiopulmonary and inflammatory response is affected by initial femoral intramedullary nailing in the already traumatized and inflammatory activated patient was analyzed in the present study with the attention to survey the additional burden of this operative treatment. The patients are monitored with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared with a standard reaming technique (TR).

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • femoral shaft fracture suitable for intramedullary nailing
  • < 24 hours postinjury

排除标准

  • previous fracture of the femur
  • pathological fracture
  • femur deformities
  • pregnancy
  • previous intramedullary nailing or external fixation

结局指标

主要结局

cardiopulmonary alterations

时间窗: the first three postoperative days

coagulation, fibrinolytic and cytokine response

时间窗: pre-, per- and first 3 days postoperatively

次要结局

  • fracture healing(1 year)

研究者

发起方
Ullevaal University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabeth Ellingsen Husebye

MD

Oslo University Hospital

研究点 (2)

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