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临床试验/NCT01394744
NCT01394744已完成不适用

Determination of Metal Ion Levels in the Serum and Assessment of the Respective Cytokine Production of Peripheral Blood Cells in Patients With a Hard-on-hard Bearing Total Hip Replacement

Ludwig-Maximilians - University of Munich2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2

研究概览

简要总结

The goal of the study is the analysis of metal ion serum concentrations and of the cytokine production in the blood of patients with a conventional cementless total hip replacement. The rationale is that a) the bearing wear releases particles respectively metal ions into the joint and the blood which will differ in quantity and composition; b) the cytokine production of peripheral blood mononuclear cells (PBMC) might be influenced to a varying degree by the metal and the ceramic particles.

The patients from whom the respective samples will be analyzed are randomized in one of the following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm bearing is used in all patients. In this separate study, follow-up data of the clinical and radiographic examinations of the patients are available.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 years, necessity of hip replacement, informed consent

排除标准

  • acute inflammatory disease, renal disease, other cobalt-chromium implant, ager over 75 years

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Thomas

Prof. Dr.

Ludwig-Maximilians - University of Munich

研究点 (2)

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