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临床试验/NCT03164733
NCT03164733Unknown不适用

Age Dependency of Biological Reaction on Wear Particles

University of Jena0 个研究点目标入组 80 人开始时间: 2017年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
biological reaction

研究概览

简要总结

Wear is the main reason for revision operations after joint arthroplasty. While the survival of modern implants is often longer than the expected life span in old patients, young patients (<60 years) have to expect at least one wear induced revision operation. The reason is the throughout all registries consistantly significantly reduced implant survival rates in young patients. In the swedish arthrplasty registry the 15 year survival for patients older than 75 years is 95 % and for those younger than 50 years is 75 %. This corresponds to a 5fold increased revision rate (5 % vs. 25 %) 15 years after implantation. This significant difference cannot be explained by the higher activity of younger patients alone. Patient specific factors, that modulate the biological reaction on wear particles, are therefore highly probable. These could explain the significant age dependency of implant survival.

The main hypothesis of this study is therefore, that the biological reaction on wear particles depends on the patients age.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • having received a total hip arthroplasty 4 weeks before blood sample for this study

排除标准

  • no informed consent

结局指标

主要结局

biological reaction

时间窗: one hour

TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro

次要结局

未报告次要终点

研究者

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

Georg Matziolis

head of the orthopaedic department

Jena University Hospital

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