Fractures in ChildrenETPNCT05625165
Epidemiology of Pediatric Traumatology
An observational study of Fractures in Children, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Fractures have been shown to account for 10-25% of injuries in children and the consequences of pediatric fractures are significant and result in significant restriction of activity. Despite this, the epidemiology of pediatric fractures remains poorly detailed. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Fractures in Children
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2020to 2 Oct 2021
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children treated in the pediatric emergency department of the Strasbourg University Hospitals between January 2014 and December 2020 for skeletal trauma
Who may be able to join
- Children treated in the pediatric emergency department of the Strasbourg University Hospitals between January 2014 and December 2020 for skeletal trauma.
- Child and Holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition
Who cannot join
- Patient or legal representative who expressed their opposition to participating in the study
- Impossibility of giving informed information to the subject
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France
Strasbourg, 67091
About this study
Fractures have been shown to account for 10-25% of injuries in children and the consequences of pediatric fractures are significant and result in significant restriction of activity. Despite this, the epidemiology of pediatric fractures remains poorly detailed.
Investigators seek to establish the incidence of pediatric trauma and fractures and determine patient, trauma and injury characteristics.
- Conditions
- Fractures in Children
- Keywords
- Fractures in Children, pediatric fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pediatric trauma and fractures and to determine the characteristics of patients, traumas and lesions
This study focuses on retrospective analysis of patients' medical records
Measured: Files analysed retrospectively from January 01, 2014 to December 31, 2012 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 posted22 Nov 2022
- Study start2 Oct 2020
- Primary completion2 Aug 2021
- Study completion2 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
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
- NCT05625165
- Sponsor's protocol ID
- 7956
- Acronym
- ETP
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 2 Nov 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Pediatric Traumatology
- ClinicalTrials.gov ID
- NCT05625165
- Acronym / sponsor ID
- ETP / 7956
- Conditions
- Fractures in Children
- Keywords
- Fractures in Children, pediatric fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 2 Oct 2021 (actual)
- First posted
- 22 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.
Fractures have been shown to account for 10-25% of injuries in children and the consequences of pediatric fractures are significant and result in significant restriction of activity. Despite this, the epidemiology of pediatric fractures remains poorly detailed.
Investigators seek to establish the incidence of pediatric trauma and fractures and determine patient, trauma and injury characteristics.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children treated in the pediatric emergency department of the Strasbourg University Hospitals between January 2014 and December 2020 for skeletal trauma
Key inclusion criteria (2 listed)
- Children treated in the pediatric emergency department of the Strasbourg University Hospitals between January 2014 and December 2020 for skeletal trauma.
- Child and Holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition
Key exclusion criteria (2 listed)
- Patient or legal representative who expressed their opposition to participating in the study
- Impossibility of giving informed information to the subject
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
Incidence of pediatric trauma and fractures and to determine the characteristics of patients, traumas and lesions
Time frame: Files analysed retrospectively from January 01, 2014 to December 31, 2012 will be examined
This study focuses on retrospective analysis of patients' medical records
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 2 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fractures in Children, 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 2 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: finished, as of the sponsor's last update on 2 Nov 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?
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?
Incidence of pediatric trauma and fractures and to determine the characteristics of patients, traumas and lesions (time frame: Files analysed retrospectively from January 01, 2014 to December 31, 2012 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 2 Nov 2023.