Pathophysiological Effects of- and Inflammatory Response to Intramedullary Femoral Nailing in Patients With Femoral Shaft Fracture
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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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with a pulmonary catheter, and blood samples for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and postoperatively.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
- 否
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
Elisabeth Ellingsen Husebye
MD
Oslo University Hospital
