Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE)

Completed

• Conditions: Congenital Funnel Chest
• Interventions: Procedure: minimally invasive repair of pectus excavatum

• Registration Number: NCT04751266
• Lead Sponsor: Dr. Caroline Fortmann

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-12
• Status Verified: 2022-04
• Primary Completion: 2022-04
• Study Completion: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• MIRPE

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with MIRPE	minimally invasive repair of pectus excavatum	first minimally invasive repair of pectus excavatum

Primary Outcome Measures

Name	Time	Method
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 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 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 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.
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.

Secondary Outcome Measures

Name	Time	Method
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.