Children Born With Club Feet

NCT03671863 | Completed

• 1 other identifier: RECHMPL18_0332
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

Clubfoot

Keywords

Ultrasound; Prenatal diagnosis; Congenital deformities; Perinatal outcome

Outcome Measures

Primary Outcomes (1)

• Antenatal detection rate of clubfeet

  Antenatal detection rate of clubfeet in percentage

  At birth

Secondary Outcomes (7)

• Rate of isolated clubfoot among children followed for clubfoot

  At birth

• Rate of refered for second-degree examination

  At birth

• Rate of invasive samples taken and their results

  At birth

• Rate of files submitted to our reference center committee

  At birth

• Research rates of musculoskeletal genetic disease

  At birth

Study Arms (1)

Infants who are treated for clubfoot

Infants who are treated for clubfoot in the reference reeducation center

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

Interventions

Invasive analysis (caryotype, CGH array) OTHER

Invasive analysis (caryotype, CGH array)

Infants who are treated for clubfoot

Prenatal management OTHER

Prenatal management

Infants who are treated for clubfoot

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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 "

You may qualify if:

• Congenital clubfoot uni or bilateral
• Have been treated in the reference center " Institut Saint Pierre, Plavas-les-flots, France "

You may not qualify if:

• \- Non confirmed clubfoot after birth

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Florent FUCHS, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 14, 2018
• Study Start: January 1, 2014
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 26, 2018

Record last verified: 2018-09

Locations

FR (1)