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Completed

NCT Number: NCT03671863

Children Born With Club Feet

Clubfoot is one of the most common birth defects, with a prevalence in Europe estimated between 1 and 4.5 for 1000 live birth.

It is useful to distinguish the forms of isolated clubfoot, and the forms related to others morphological abnormalities (complex clubfoot). For the complex forms, the clubfoot can be integrated in a syndromic association, be the consequence of a serious harm of the central nervous system, be associate to a genetic musculo-skeletal disease or wether be associated to a karyotype abnormality.

In those cases, the prognosis depends more about the associated morphological abnormalities that can be the beginning of a severe disability or incompatible with life or any anomaly of the karyotype that clubfoot itself.

In case of several morphological abnormalities, to propose invasive samples with realization of a karyotype and chromosome analysis with CGH array is a consensual attitude.

What the investigators should recommended to the parents in case of isolated form is less obvious and the question of antenatal investigations can not be answered clearly in the literature. Thus, the management of these patients may vary from one CPDP to another.

This study project will make it possible to analyze the management offered to patients whose fetuses have club feet and to study the results of the various examinations carried out in order to adapt the prenatal counselling and to define the best diagnostic strategy to propose to the future parents.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Congenital clubfoot uni or bilateral
  • Have been treated in the reference center " Institut Saint Pierre, Plavas-les-flots, France "

Exclusion criteria

  • Non confirmed clubfoot after birth

Treatment and study plan

Invasive analysis (caryotype, CGH array)

Other

Invasive analysis (caryotype, CGH array)

Prenatal management

Other

Prenatal management

Primary outcomes

  1. Antenatal detection rate of clubfeet

    Time frame: At birth

    Antenatal detection rate of clubfeet in percentage

Secondary outcomes

  1. Rate of isolated clubfoot among children followed for clubfoot

    Time frame: At birth

    Rate of isolated clubfoot among children followed for clubfoot in percentage

  2. Rate of refered for second-degree examination

    Time frame: At birth

    Rate of refered for second-degree examination in percentage

  3. Rate of invasive samples taken and their results

    Time frame: At birth

    Rate of invasive samples taken and their results in percentage

  4. Rate of files submitted to our reference center committee

    Time frame: At birth

    Rate of files submitted to our reference center committee in percentage

  5. Research rates of musculoskeletal genetic disease

    Time frame: At birth

    Research rates of musculoskeletal genetic disease in percentage

  6. Rate of consultation with geneticist

    Time frame: At birth

    Rate of consultation with geneticist in percentage

  7. Rate of consultation with a orthopedic surgeon

    Time frame: At birth

    Rate of consultation with a orthopedic surgeon in percentage

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Children Born With Club Feet: Ultrasound Diagnosis and Antenatal Assessment

Acronym: CBCF

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2018
Registry last updated
Sep 26, 2018

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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