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临床试验/NCT02262065
NCT02262065已完成不适用

Individual Risk Factors for Enhanced Inflammation to Arthroplasty Wear Particles: Analysis of Cytokine Polymorphisms and in Vitro Cytokine Production to Wear Particles (Ceramic, Metal, XPE)

Ludwig-Maximilians - University of Munich1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2012年7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
195
试验地点
1
主要终点
Polymorphism frequency

研究概览

简要总结

Assessment of cytokine polymorphisms in 100 patients with aseptic complications to arthroplasty as compared to 100 symptom-free arthroplasty patients.

In selected patients additional in-vitro cytokine release assay with peripheral blood mononuclear cells (PBMC) stimulated with different wear particles.

详细描述

A cytokine polymorphism analysis in 100 individuals with aseptic implant intolerance reaction (patients of the implant allergy special ambulance) and in 100 asymptomatic patients with implanted endoprostheses will be done. Furthermore, supplementary clinical data (such as type of implant, hospital stay, discomfort), questionnaire-based history and a clinical score (WOMAC score) are recorded. In the subgroup analysis in 10 patients of implant patients with complaints with special found cytokine polymorphisms and 10 implant patients without problems the cytokine response to particles in vitro will assessed.

Test parameters:

  1. total collective:

the DNA of cryopreserved blood sample will be isolated. By polymerase chain reaction, four different known polymorphisms will be analyzed, three IL-1B genes (IL-1B-3954 IL-1B-31, and IL-1B-511), and a IL-1ß receptor antagonist gene (IL -1-RN, intron 2 VNTR). Molecular analysis includes DNA isolation, polymerase chain reactions (PCR) and gel electrophoresis. 2. Subgroup analysis:

Peripheral blood cells will be isolated from 10 implant patients with complications and 10 symptom-free persons and stimulated in cell culture with control stimuli, the IL-1ß-inducer lipopolysaccharide (LPS) and ceramic particles (BIOLOX delta)*, CoCrMo particles and XPE-particles** cultured separately or in combination. The secretion of IL-1ß and selected proinflammatory cytokines will be measured. The methods include cell isolation by density centrifugation and analysis of cell culture supernatants by a multiplex cytokine measurement assay by flow cytometry.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • arthroplasty
  • over 18 years
  • no infection

排除标准

  • inability to consent
  • malposition
  • infection

结局指标

主要结局

Polymorphism frequency

时间窗: 2 years

Frequency of 4 different cytokine polymorphisms will be assessed in the 2 study groups.

次要结局

  • Cytokine production(1 year)

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 (1)

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