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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03671863
Other study ID # RECHMPL18_0332
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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