An observational study in Congenital Funnel Chest, sponsored by Dr. Caroline Fortmann. Completed. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by Dr. Caroline Fortmann · Observational
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's enrollment of 28 is below the median of 68 across 32 observational studies indexed under Funnel Chest.
Browse Funnel Chest studies →This is the only study on the registry with Dr. Caroline Fortmann as lead sponsor.
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primary care clinic
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Exclusion Criteria:
first minimally invasive repair of pectus excavatum
Procedure: minimally invasive repair of pectus excavatum
substernal insertion of a metal bar
change of mean chromium values in blood (µg/l)
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.
Time frame: 4 years
change of mean chromium values in urine (µg/l)
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.
Time frame: 4 years
change of mean chromium values in tissue (µg/g)
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.
Time frame: 3 years
change of mean nickel values in blood (µg/l)
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.
Time frame: 4 years
change of mean nickel values in urine (µg/l)
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.
Time frame: 4 years
change of mean nickel values in tissue (µg/g)
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.
Time frame: 3 years
Observation of clinical reactions in correlation with elevated metal values
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.
Time frame: 4 years
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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