Children Born With Club Feet

Clubfoot Clinical Trial

— CBCF  

Official title:

Children Born With Club Feet: Ultrasound Diagnosis and Antenatal Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671863
• Other study ID #: RECHMPL18_0332
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Clubfoot

Intervention

Other:
• Invasive analysis (caryotype, CGH array)
Invasive analysis (caryotype, CGH array)
• Prenatal management
Prenatal management

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antenatal detection rate of clubfeet	Antenatal detection rate of clubfeet in percentage	At birth
Secondary	Rate of isolated clubfoot among children followed for clubfoot	Rate of isolated clubfoot among children followed for clubfoot in percentage	At birth
Secondary	Rate of refered for second-degree examination	Rate of refered for second-degree examination in percentage	At birth
Secondary	Rate of invasive samples taken and their results	Rate of invasive samples taken and their results in percentage	At birth
Secondary	Rate of files submitted to our reference center committee	Rate of files submitted to our reference center committee in percentage	At birth
Secondary	Research rates of musculoskeletal genetic disease	Research rates of musculoskeletal genetic disease in percentage	At birth
Secondary	Rate of consultation with geneticist	Rate of consultation with geneticist in percentage	At birth
Secondary	Rate of consultation with a orthopedic surgeon	Rate of consultation with a orthopedic surgeon in percentage	At birth