Children Born With Club Feet (CBCF)

Children Born With Club Feet: Ultrasound Diagnosis and Antenatal Assessment

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.

Study Overview

• Status: Completed
• Conditions: Clubfoot
• Intervention / Treatment: Other: Invasive analysis (caryotype, CGH array); Other: Prenatal management

• Study Type: Observational
• Enrollment (Actual): 219

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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 "

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Prenatal management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antenatal detection rate of clubfeet	Antenatal detection rate of clubfeet in percentage	At birth

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Florent FUCHS, PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; Perinatal outcome; Prenatal diagnosis; Congenital deformities
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Clubfoot
• Other Study ID Numbers: RECHMPL18_0332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No