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| Name | Class |
|---|---|
| Friedrich-Alexander-Universität Erlangen-Nürnberg | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with MIRPE | first minimally invasive repair of pectus excavatum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| minimally invasive repair of pectus excavatum | Procedure | substernal insertion of a metal bar |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of mean chromium values in blood (µg/l) | measurement of: 1) chromium in blood (in µg/l) at the time points:
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. | 4 years |
| change of mean chromium values in urine (µg/l) | measurement of: 2) chromium in urine (in µg/l) at the time points:
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. | 4 years |
| change of mean chromium values in tissue (µg/g) | measurement of: 3) chromium in tissue (in µg/g) at the time points:
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. | 3 years |
| change of mean nickel values in blood (µg/l) | measurement of: 4) nickel in blood (in µg/l) at the time points:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Observation of clinical reactions in correlation with elevated metal values | observation (description) of clinical symptoms of a metal allergy like
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. |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Fortmann, MD | Department of Pediatric Surgery | Principal Investigator |
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| ID | Term |
|---|---|
| D005660 | Funnel Chest |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
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whole blood, urine, tissue
| 4 years |
| change of mean nickel values in urine (µg/l) | measurement of: 5) nickel in urine (in µg/l) at the time points:
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. | 4 years |
| change of mean nickel values in tissue (µg/g) | measurement of: 6) nickel in tissue (in µg/g) at the time points:
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. | 3 years |
| 4 years |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |