Congenital Funnel Chest Clinical Trial
Official title:
Examination of Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE) and the Clinical Relevance
| NCT number | NCT04751266 |
| Other study ID # | 6659 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2015 |
| Est. completion date | April 2022 |
| Verified date | April 2022 |
| Source | Hannover Medical School |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | April 2022 |
| Est. primary completion date | April 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 45 Years |
| Eligibility | Inclusion Criteria: - MIRPE Exclusion Criteria: - none |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Dr. Caroline Fortmann | Friedrich-Alexander-Universität Erlangen-Nürnberg |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change of mean chromium values in blood (µg/l) | measurement of:
1) chromium in blood (in µg/l) at the time points: pre implantation 4 weeks after implantation (to see change to baseline) 1 year after implantation (to see change to baseline) 2 years after implantation (to see change to baseline) explantation (usually 3 years after implantation; to see change to baseline) 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. |
4 years | |
| Primary | change of mean chromium values in urine (µg/l) | measurement of: 2) chromium in urine (in µg/l)
at the time points: pre implantation 4 weeks after implantation (to see change to baseline) 1 year after implantation (to see change to baseline) 2 years after implantation (to see change to baseline) explantation (usually 3 years after implantation; to see change to baseline) 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. |
4 years | |
| Primary | change of mean chromium values in tissue (µg/g) | measurement of: 3) chromium in tissue (in µg/g)
at the time points: implantation 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. |
3 years | |
| Primary | change of mean nickel values in blood (µg/l) | measurement of: 4) nickel in blood (in µg/l)
at the time points: pre implantation 4 weeks after implantation (to see change to baseline) 1 year after implantation (to see change to baseline) 2 years after implantation (to see change to baseline) explantation (usually 3 years after implantation; to see change to baseline) 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. |
4 years | |
| Primary | change of mean nickel values in urine (µg/l) | measurement of: 5) nickel in urine (in µg/l)
at the time points: pre implantation 4 weeks after implantation (to see change to baseline) 1 year after implantation (to see change to baseline) 2 years after implantation (to see change to baseline) explantation (usually 3 years after implantation; to see change to baseline) 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. |
4 years | |
| Primary | change of mean nickel values in tissue (µg/g) | measurement of: 6) nickel in tissue (in µg/g)
at the time points: implantation 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. |
3 years | |
| Secondary | 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. |
4 years |