Examination of Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE) and the Clinical Relevance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- change of mean chromium values in urine (µg/l)
研究概览
简要总结
The purpose of this study is to determine whether there is a metal wear debris after minimally invasive repair of pectus excavatum and if there's a clinical relevance. Our hypothesis is that the metal bar after minimally invasive repair of pectus excavatum leads to a locally and systemic immune reaction due to elevated metal contamination.
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
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
change of mean chromium values in urine (µg/l)
时间窗: 4 years
measurement of: 2) chromium in urine (in µg/l) at the time points: 1. pre implantation 2. 4 weeks after implantation (to see change to baseline) 3. 1 year after implantation (to see change to baseline) 4. 2 years after implantation (to see change to baseline) 5. explantation (usually 3 years after implantation; to see change to baseline) 6. 6-12 months after explantation (to see change to explantation) We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
change of mean chromium values in blood (µg/l)
时间窗: 4 years
measurement of: 1) chromium in blood (in µg/l) at the time points: 1. pre implantation 2. 4 weeks after implantation (to see change to baseline) 3. 1 year after implantation (to see change to baseline) 4. 2 years after implantation (to see change to baseline) 5. explantation (usually 3 years after implantation; to see change to baseline) 6. 6-12 months after explantation (to see change to explantation) We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
change of mean chromium values in tissue (µg/g)
时间窗: 3 years
measurement of: 3) chromium in tissue (in µg/g) at the time points: 1. implantation 2. explantation (usually 3 years after implantation; to see change to baseline) We will compare the mean metal values at explantation with the mean metal values before implantation. Clinical data like body weight etc. won't be relevant for the analysis.
change of mean nickel values in tissue (µg/g)
时间窗: 3 years
measurement of: 6) nickel in tissue (in µg/g) at the time points: 1. implantation 2. explantation (usually 3 years after implantation; to see change to baseline) We will compare the mean metal values at explantation with the mean metal values before implantation. Clinical data like body weight etc. won't be relevant for the analysis.
change of mean nickel values in blood (µg/l)
时间窗: 4 years
measurement of: 4) nickel in blood (in µg/l) at the time points: 1. pre implantation 2. 4 weeks after implantation (to see change to baseline) 3. 1 year after implantation (to see change to baseline) 4. 2 years after implantation (to see change to baseline) 5. explantation (usually 3 years after implantation; to see change to baseline) 6. 6-12 months after explantation (to see change to explantation) We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
change of mean nickel values in urine (µg/l)
时间窗: 4 years
measurement of: 5) nickel in urine (in µg/l) at the time points: 1. pre implantation 2. 4 weeks after implantation (to see change to baseline) 3. 1 year after implantation (to see change to baseline) 4. 2 years after implantation (to see change to baseline) 5. explantation (usually 3 years after implantation; to see change to baseline) 6. 6-12 months after explantation (to see change to explantation) We will compare the mean metal values at each time point post implantation with the mean metal values pre implantation. Clinical data like body weight etc. won't be relevant for the analysis.
次要结局
- Observation of clinical reactions in correlation with elevated metal values(4 years)
研究者
Dr. Caroline Fortmann
Principal Investigator
Hannover Medical School