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Completed

NCT Number: NCT04751266

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

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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Key information

Conditions

Congenital Funnel Chest Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • MIRPE

Exclusion criteria

  • none

Treatment and study plan

minimally invasive repair of pectus excavatum

Procedure

substernal insertion of a metal bar

Primary outcomes

  1. change of mean chromium values in blood (µg/l)

    Time frame: 4 years

    measurement of:

    • 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.

  2. 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:

    • 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.

  3. 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:

    • 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.

  4. 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:

    • 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.

  5. 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:

    • 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.

  6. 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:

    • 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dr. Caroline Fortmann

Other

Collaborators

  • Friedrich-Alexander-Universität Erlangen-Nürnberg

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2021
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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