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Children Born With Club Feet (CBCF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671863
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Clubfoot Other: Invasive analysis (caryotype, CGH array) Other: Prenatal management

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Study Type : Observational
Actual Enrollment : 219 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Children Born With Club Feet: Ultrasound Diagnosis and Antenatal Assessment
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




Primary Outcome Measures :
  1. Antenatal detection rate of clubfeet [ Time Frame: At birth ]
    Antenatal detection rate of clubfeet in percentage


Secondary Outcome Measures :
  1. Rate of isolated clubfoot among children followed for clubfoot [ Time Frame: At birth ]
    Rate of isolated clubfoot among children followed for clubfoot in percentage

  2. Rate of refered for second-degree examination [ Time Frame: At birth ]
    Rate of refered for second-degree examination in percentage

  3. Rate of invasive samples taken and their results [ Time Frame: At birth ]
    Rate of invasive samples taken and their results in percentage

  4. Rate of files submitted to our reference center committee [ Time Frame: At birth ]
    Rate of files submitted to our reference center committee in percentage

  5. Research rates of musculoskeletal genetic disease [ Time Frame: At birth ]
    Research rates of musculoskeletal genetic disease in percentage

  6. Rate of consultation with geneticist [ Time Frame: At birth ]
    Rate of consultation with geneticist in percentage

  7. Rate of consultation with a orthopedic surgeon [ Time Frame: At birth ]
    Rate of consultation with a orthopedic surgeon in percentage



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 "
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671863


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Florent FUCHS, PhD University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03671863    
Other Study ID Numbers: RECHMPL18_0332
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Ultrasound
Prenatal diagnosis
Congenital deformities
Perinatal outcome
Additional relevant MeSH terms:
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Clubfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities