Congenital Funnel Chest
Conditions
Brief summary
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.
Interventions
substernal insertion of a metal bar
Sponsors
Friedrich-Alexander-Universität Erlangen-Nürnberg
Dr. Caroline Fortmann
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* MIRPE
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of mean chromium values in blood (µg/l) | 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 urine (µg/l) | 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 tissue (µg/g) | 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 blood (µg/l) | 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) | 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. |
| change of mean nickel values in tissue (µg/g) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observation of clinical reactions in correlation with elevated metal values | 4 years | observation (description) of clinical symptoms of a metal allergy like * local rash * lassitude * chest pain * tachycardia * Nausea * pleural effusion for the time the bar is in place (3 years) and the metal values are evaluated. -\> Then compare the mean metal values (see above) with the baseline and the other patients (with and/or without problems) No records when the patients don't have any problems. |
Outcome results
None listed