Children Born With Club Feet

NCT ID: NCT03671863

Last Updated: 2018-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Clubfoot

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Infants who are treated for clubfoot

Infants who are treated for clubfoot in the reference reeducation center

Invasive analysis (caryotype, CGH array)

Intervention Type OTHER

Invasive analysis (caryotype, CGH array)

Prenatal management

Intervention Type OTHER

Prenatal management

Interventions

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Invasive analysis (caryotype, CGH array)

Invasive analysis (caryotype, CGH array)

Intervention Type OTHER

Prenatal management

Prenatal management

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florent FUCHS, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL18_0332

Identifier Type: -

Identifier Source: org_study_id

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