Children Born With Club Feet

Completed

• Conditions: Clubfoot
• Interventions: Other: Invasive analysis (caryotype, CGH array); Other: Prenatal management

• Registration Number: NCT03671863
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-09
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants who are treated for clubfoot	Prenatal management	Infants who are treated for clubfoot in the reference reeducation center
Infants who are treated for clubfoot	Invasive analysis (caryotype, CGH array)	Infants who are treated for clubfoot in the reference reeducation center

Primary Outcome Measures

Name	Time	Method
Antenatal detection rate of clubfeet	At birth	Antenatal detection rate of clubfeet in percentage

Secondary Outcome Measures

Name	Time	Method
Rate of consultation with geneticist	At birth	Rate of consultation with geneticist in percentage
Rate of consultation with a orthopedic surgeon	At birth	Rate of consultation with a orthopedic surgeon in percentage
Rate of isolated clubfoot among children followed for clubfoot	At birth	Rate of isolated clubfoot among children followed for clubfoot in percentage
Rate of refered for second-degree examination	At birth	Rate of refered for second-degree examination in percentage
Rate of invasive samples taken and their results	At birth	Rate of invasive samples taken and their results in percentage
Rate of files submitted to our reference center committee	At birth	Rate of files submitted to our reference center committee in percentage
Research rates of musculoskeletal genetic disease	At birth	Research rates of musculoskeletal genetic disease in percentage

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France