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临床试验/NCT00859378
NCT00859378Unknown不适用

A Prospective, Randomized Study Comparing Cemented and Non-cemented Semiendoprostheses in the Treatment of Proximal Femoral Fractures in the Elderly Patients

Kuopio University Hospital4 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2008年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
4
主要终点
Primary mortality

研究概览

简要总结

The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures. Traditionally, the cemented version of the semiendoprosthesis has been used for this indication. However, the cementing carries a risk of fat embolism during the pressurization of the cement. The fat embolism can be avoided when using the non-cemented semiendoprosthesis. In this study we want to find out whether there are any differences in the treatment results between the cemented and non-cemented semiendoprostheses when treating the proximal femoral fractures.

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

性别
All
接受健康志愿者

入选标准

  • A proximal femoral fracture

排除标准

  • Rheumatoid arthritis
  • Pathologic fracture
  • Severe dementia (preventing the informed consent)

结局指标

主要结局

Primary mortality

时间窗: 3 months

次要结局

  • Prosthetic complications(1 year)

研究者

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

Tero Yli-Kyyny

M.D.

Kuopio University Hospital

研究点 (4)

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