Femur Fracture, ChildhoodGFINCT05620394
Study of the Geometry of the Immature Human Femur Before the Age of 3 Years From Data Measured on CT Scan
An observational study of Femur Fracture, Childhood, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Childhood fractures are the second most common presentation of abuse. The target population for screening for these injuries is children under the age of three who are unable to express themselves about the circumstances of the trauma, hence the need to develop a validated model to predict the outcome of trauma as… Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Femur Fracture, Childhood
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2020to 31 Dec 2023
- 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 3 years
- All sexes
- Child
Study population: Minor patient who died before the age of 3 years
Who may be able to join
- Minor patient who died before the age of 3 years
- Whole body CT imaging performed post mortem on judicial requisition in the framework of a forensic procedure
- Absence of refusal in the medical file by the holders of parental authority concerning the re-use of their child's data for the purposes of this research
Who cannot join
- Refusal manifested in the medical record by parental authority holders regarding the reuse of their child's data for the purpose of this research,
- Femur not fully assessable on imaging acquisition
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Légale et Toxicologie - CHU de Strasbourg - France
Strasbourg, 67091
Jean-Sébastien RAUL, MD, PhD, 33 3 69 55 10 34, jean-sebastien.raul@chru-strasbourg.fr
Jean-Sébastien RAUL, MD, PhD
About this study
Childhood fractures are the second most common presentation of abuse. The target population for screening for these injuries is children under the age of three who are unable to express themselves about the circumstances of the trauma, hence the need to develop a validated model to predict the outcome of trauma as well as the origin of a fracture.
Few morphological data are available in the literature for the femur concerning the period of rapid growth between 0 and 3 years of age.
- Conditions
- Femur Fracture, Childhood
- Keywords
- Femur Fracture, Childhood
- Medical subject headings
- Femoral Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
To retrospectively characterize the variations in femur morphology during growth in a target pediatric population aged 0 to 3 years
To retrospectively characterize the variations in femur morphology during growth in a target pediatric population aged 0 to 3 years with the aim of later developing a numerical model to study fracture mechanisms for forensic applications
Measured: Files analysed retrospectively from January 01, 2015 to February 29, 2020 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start7 Oct 2020
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur Fracture, ChildhoodStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620394
- Sponsor's protocol ID
- 7714
- Acronym
- GFI
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Geometry of the Immature Human Femur Before the Age of 3 Years From Data Measured on CT Scan
- ClinicalTrials.gov ID
- NCT05620394
- Acronym / sponsor ID
- GFI / 7714
- Conditions
- Femur Fracture, Childhood
- Keywords
- Femur Fracture, Childhood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Nov 2022 (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.
Childhood fractures are the second most common presentation of abuse. The target population for screening for these injuries is children under the age of three who are unable to express themselves about the circumstances of the trauma, hence the need to develop a validated model to predict the outcome of trauma as well as the origin of a fracture.
Few morphological data are available in the literature for the femur concerning the period of rapid growth between 0 and 3 years of age.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Age groups
- Child
- Study population
- Minor patient who died before the age of 3 years
Key inclusion criteria (3 listed)
- Minor patient who died before the age of 3 years
- Whole body CT imaging performed post mortem on judicial requisition in the framework of a forensic procedure
- Absence of refusal in the medical file by the holders of parental authority concerning the re-use of their child's data for the purposes of this research
Key exclusion criteria (2 listed)
- Refusal manifested in the medical record by parental authority holders regarding the reuse of their child's data for the purpose of this research,
- Femur not fully assessable on imaging acquisition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To retrospectively characterize the variations in femur morphology during growth in a target pediatric population aged 0 to 3 years
Time frame: Files analysed retrospectively from January 01, 2015 to February 29, 2020 will be examined
To retrospectively characterize the variations in femur morphology during growth in a target pediatric population aged 0 to 3 years with the aim of later developing a numerical model to study fracture mechanisms for forensic applications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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.
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 Femur Fracture, Childhood, run by University Hospital, Strasbourg, France 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Sébastien RAUL, MD, PhD (33 3 69 55 10 34, jean-sebastien.raul@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To retrospectively characterize the variations in femur morphology during growth in a target pediatric population aged 0 to 3 years (time frame: Files analysed retrospectively from January 01, 2015 to February 29, 2020 will be examined). 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 31 Oct 2023.