Clinical trial NCT03671863: Children Born With Club Feet
Official title: Children Born With Club Feet: Ultrasound Diagnosis and Antenatal Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clubfoot
Keywords: Ultrasound
Prenatal diagnosis
Congenital deformities
Perinatal outcome
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 219
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with a clubfoot, antenatal diagned or not, treated at the " Institut Saint Pierre, Plavas-les-flots, France "

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Antenatal detection rate of clubfeet
timeFrame: At birth
Secondary outcomes:
measure: Rate of isolated clubfoot among children followed for clubfoot
timeFrame: At birth
measure: Rate of refered for second-degree examination
timeFrame: At birth
measure: Rate of invasive samples taken and their results
timeFrame: At birth
measure: Rate of files submitted to our reference center committee
timeFrame: At birth
measure: Research rates of musculoskeletal genetic disease
timeFrame: At birth
measure: Rate of consultation with geneticist
timeFrame: At birth
measure: Rate of consultation with a orthopedic surgeon
timeFrame: At birth
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florent FUCHS, PhD
role: PRINCIPAL_INVESTIGATOR
References: