ClubfootCBCFNCT03671863
Children Born With Club Feet
An observational study of Clubfoot, run by University Hospital, Montpellier at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Clubfoot
- What is being tested?
- Invasive analysis (caryotype, CGH array) and Prenatal management
- How many people
- 219 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants with a clubfoot, antenatal diagned or not, treated at the " Institut Saint Pierre, Plavas-les-flots, France "
Who may be able to join
- Congenital clubfoot uni or bilateral
- Have been treated in the reference center " Institut Saint Pierre, Plavas-les-flots, France "
Who cannot join
- Non confirmed clubfoot after birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Invasive analysis (caryotype, CGH array), Prenatal management
- Keywords
- Ultrasound, Prenatal diagnosis, Congenital deformities, Perinatal outcome
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive analysis (caryotype, CGH array)Other
Invasive analysis (caryotype, CGH array)
Prenatal managementOther
Prenatal management
| Study group | Role | What they receive |
|---|---|---|
| Infants who are treated for clubfoot | Infants who are treated for clubfoot in the reference reeducation center Receives: Other: Invasive analysis (caryotype, CGH array); Other: Prenatal management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antenatal detection rate of clubfeet
Antenatal detection rate of clubfeet in percentage
Measured: At birth
Secondary outcomes (7)
Rate of isolated clubfoot among children followed for clubfoot
Rate of isolated clubfoot among children followed for clubfoot in percentage
Measured: At birth
Rate of refered for second-degree examination
Rate of refered for second-degree examination in percentage
Measured: At birth
Rate of invasive samples taken and their results
Rate of invasive samples taken and their results in percentage
Measured: At birth
Rate of files submitted to our reference center committee
Rate of files submitted to our reference center committee in percentage
Measured: At birth
Research rates of musculoskeletal genetic disease
Research rates of musculoskeletal genetic disease in percentage
Measured: At birth
Rate of consultation with geneticist
Rate of consultation with geneticist in percentage
Measured: At birth
Rate of consultation with a orthopedic surgeon
Rate of consultation with a orthopedic surgeon in percentage
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Jan 2014
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent FUCHS, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671863
- Sponsor's protocol ID
- RECHMPL18_0332
- Acronym
- CBCF
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children Born With Club Feet: Ultrasound Diagnosis and Antenatal Assessment
- ClinicalTrials.gov ID
- NCT03671863
- Acronym / sponsor ID
- CBCF / RECHMPL18_0332
- Conditions
- Clubfoot
- Keywords
- Ultrasound, Prenatal diagnosis, Congenital deformities, Perinatal outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants who are treated for clubfoot | – | Other: Invasive analysis (caryotype, CGH array), Other: Prenatal managementInfants who are treated for clubfoot in the reference reeducation center |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with a clubfoot, antenatal diagned or not, treated at the " Institut Saint Pierre, Plavas-les-flots, France "
Key inclusion criteria (2 listed)
- Congenital clubfoot uni or bilateral
- Have been treated in the reference center " Institut Saint Pierre, Plavas-les-flots, France "
Key exclusion criteria (1 listed)
- Non confirmed clubfoot after birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive analysis (caryotype, CGH array)Invasive analysis (caryotype, CGH array) | Other | Infants who are treated for clubfoot |
| Prenatal managementPrenatal management | Other | Infants who are treated for clubfoot |
Primary outcome
Antenatal detection rate of clubfeet
Time frame: At birth
Antenatal detection rate of clubfeet in percentage
7 secondary outcomes
Rate of isolated clubfoot among children followed for clubfoot
Time frame: At birth
Rate of refered for second-degree examination
Time frame: At birth
Rate of invasive samples taken and their results
Time frame: At birth
Rate of files submitted to our reference center committee
Time frame: At birth
Research rates of musculoskeletal genetic disease
Time frame: At birth
Rate of consultation with geneticist
Time frame: At birth
Rate of consultation with a orthopedic surgeon
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Clubfoot
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florent FUCHS, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antenatal detection rate of clubfeet (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.