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

April 12, 2022 updated by: Dr. Caroline Fortmann

Examination of Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE) and the Clinical Relevance

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

  • MIRPE

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with MIRPE
first minimally invasive repair of pectus excavatum
Procedure: minimally invasive repair of pectus excavatum
substernal insertion of a metal bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of mean chromium values in blood (µg/l)
Time Frame: 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.
4 years
change of mean chromium values in urine (µg/l)
Time Frame: 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.
4 years
change of mean chromium values in tissue (µg/g)
Time Frame: 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.
3 years
change of mean nickel values in blood (µg/l)
Time Frame: 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.
4 years
change of mean nickel values in urine (µg/l)
Time Frame: 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.
4 years
change of mean nickel values in tissue (µg/g)
Time Frame: 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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observation of clinical reactions in correlation with elevated metal values
Time Frame: 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.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Caroline Fortmann

Collaborators

Friedrich-Alexander-Universität Erlangen-Nürnberg

Investigators

  • Principal Investigator: Caroline Fortmann, MD, Department of Pediatric Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6659

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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