A Prospective Randomized Multicenter Study on Cemented and Non-cemented Hemiprosthesis in Older Patients With Dislocated Hip Fracture.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The objective is to study the overall frequency and cumulative rate (during one year) of clinical morbidity (defined as any hospitalization without fatal outcome) and mortality in all consecutive patients undergoing HF surgery (pins and prosthetic implants) and compare this to the group of patients receiving prosthetic implants and further find out if there is a difference between the non-cemented and cemented groups.
Between the same prosthetic groups, the investigators want to study the overall frequency of in-hospital subclinical organ damage and dysfunction of myocardium, liver and lungs, using biochemical plasma markers. Finally, the investigators want to perform perioperative cost benefit calculations and out of hospital quality of life analysis between the surgical groups.
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
- None
入排标准
- 年龄范围
- 75 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Garden 3 or 4 fracture in acute hip fractures.
- •Age over 75 years.
排除标准
- •Patient or relative refuse enrollment
研究组 & 干预措施
1
Cemented hemiprosthesis
2
Non-cemented hemiprosthesis
干预措施: cemented Landos prosthesis vs. uncemented Landos prosthesis (Procedure)
结局指标
主要结局
Mortality
时间窗: 1 year after surgery
次要结局
未报告次要终点
