Children Born With Club Feet (CBCF)
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|ClinicalTrials.gov Identifier: NCT03671863|
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : September 26, 2018
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.
|Condition or disease||Intervention/treatment|
|Clubfoot||Other: Invasive analysis (caryotype, CGH array) Other: Prenatal management|
|Study Type :||Observational|
|Actual Enrollment :||219 participants|
|Official Title:||Children Born With Club Feet: Ultrasound Diagnosis and Antenatal Assessment|
|Actual Study Start Date :||January 1, 2014|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||August 31, 2018|
Infants who are treated for clubfoot
Infants who are treated for clubfoot in the reference reeducation center
Other: Invasive analysis (caryotype, CGH array)
Invasive analysis (caryotype, CGH array)
Other: Prenatal management
- Antenatal detection rate of clubfeet [ Time Frame: At birth ]Antenatal detection rate of clubfeet in percentage
- Rate of isolated clubfoot among children followed for clubfoot [ Time Frame: At birth ]Rate of isolated clubfoot among children followed for clubfoot in percentage
- Rate of refered for second-degree examination [ Time Frame: At birth ]Rate of refered for second-degree examination in percentage
- Rate of invasive samples taken and their results [ Time Frame: At birth ]Rate of invasive samples taken and their results in percentage
- Rate of files submitted to our reference center committee [ Time Frame: At birth ]Rate of files submitted to our reference center committee in percentage
- Research rates of musculoskeletal genetic disease [ Time Frame: At birth ]Research rates of musculoskeletal genetic disease in percentage
- Rate of consultation with geneticist [ Time Frame: At birth ]Rate of consultation with geneticist in percentage
- Rate of consultation with a orthopedic surgeon [ Time Frame: At birth ]Rate of consultation with a orthopedic surgeon in percentage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671863
|Montpellier, France, 34295|
|Principal Investigator:||Florent FUCHS, PhD||University Hospital, Montpellier|