跳至主要内容
临床试验/NCT00800124
NCT00800124已完成不适用

A Prospective Randomized Multicenter Study on Cemented and Non-cemented Hemiprosthesis in Older Patients With Dislocated Hip Fracture.

Sykehuset Innlandet HF1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2005年6月1日最近更新:
适应症
干预措施

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

No Intervention

Cemented hemiprosthesis

2

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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