Fractures in ChildrenDFENCT05625152
Dating of Child Fractures : Chronological Repers From the Radiological Evolution of a Series of Femur Fractures
An observational study of Fractures in Children, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Although several studies have studied the predictive nature of non-accidental trauma of the different types of fractures and in particular on the femur, the physiological and radiological particularities of the child make it difficult to estimate the age of a fracture and require defining a chronology specific to the… 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
- 15 Sep 2020to 31 Dec 2022
- 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: Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020
Who may be able to join
- Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020
- Fracture of the femur resulting from orthopedic treatment instituted during a period of hospitalization
- 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
- Fracture of the femur having benefited from a surgical intervention
- Weakening metabolic or bone pathology
- Fracture on pathological focal lesion
- Fractures of the epiphysis or affecting the growth cartilage
- 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
Although several studies have studied the predictive nature of non-accidental trauma of the different types of fractures and in particular on the femur, the physiological and radiological particularities of the child make it difficult to estimate the age of a fracture and require defining a chronology specific to the specificities of the pediatric population. Some authors have carried out work for the dating of fractures, however the number of cases or the average age of the subjects does not allow a precise estimation of the chronology of evolution of the fractures.
- Conditions
- Fractures in Children
- Keywords
- Femur Fracture, FRACTURES IN CHILDREN, Pediatric population, Bony Callus
- Medical subject headings
- Femoral Fractures, Callosities
What is being measured
The primary outcome is the main question the study is designed to answer.
Define retrospectively the chronology of the appearance of periosteal callus, secondary callus and remodeling phenomena from the study of radiographs of the femur
Evaluation of the time to radiographic appearance of the following stages defined by the number of days elapsed between the date of diagnosis of the fracture and the first radiography taken during follow-up, making it possible to highlight one of these phenomena:
- The radiographic periosteal reaction (or periosteal callus) defined by an opacity at the periphery of the fracture, corresponding to the first objectifiable calcification of the fracture hematoma and under the periosteum.
- The secondary bone callus (or osteochondral) defined by a well-defined bone apposition of density close to that of the bone with opacification of the fracture line and union of the fracture site
- Established remodeling activity when phenomena of axis correction, resorption of initial callus hypertrophy or re-permeabilizatio of the diaphyseal shaft can be demonstrated
Measured: Files analysed retrospectively from January 01, 2007 to December 31, 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 posted22 Nov 2022
- Study start15 Sep 2020
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
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 only
- 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
- NCT05625152
- Sponsor's protocol ID
- 7955
- Acronym
- DFE
- 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
- Dating of Child Fractures : Chronological Repers From the Radiological Evolution of a Series of Femur Fractures
- ClinicalTrials.gov ID
- NCT05625152
- Acronym / sponsor ID
- DFE / 7955
- Conditions
- Fractures in Children
- Keywords
- Femur Fracture, FRACTURES IN CHILDREN, Pediatric population, Bony Callus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (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.
Although several studies have studied the predictive nature of non-accidental trauma of the different types of fractures and in particular on the femur, the physiological and radiological particularities of the child make it difficult to estimate the age of a fracture and require defining a chronology specific to the specificities of the pediatric population. Some authors have carried out work for the dating of fractures, however the number of cases or the average age of the subjects does not allow a precise estimation of the chronology of evolution of the fractures.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020
Key inclusion criteria (3 listed)
- Child aged 18, cared for in the pediatric orthopedic department of the Strasbourg University Hospitals between January 2007 and December 2020
- Fracture of the femur resulting from orthopedic treatment instituted during a period of hospitalization
- 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 (6 listed)
- Patient or legal representative who expressed their opposition to participating in the study
- Fracture of the femur having benefited from a surgical intervention
- Weakening metabolic or bone pathology
- Fracture on pathological focal lesion
- Fractures of the epiphysis or affecting the growth cartilage
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
Define retrospectively the chronology of the appearance of periosteal callus, secondary callus and remodeling phenomena from the study of radiographs of the femur
Time frame: Files analysed retrospectively from January 01, 2007 to December 31, 2020 will be examined
Evaluation of the time to radiographic appearance of the following stages defined by the number of days elapsed between the date of diagnosis of the fracture and the first radiography taken during follow-up, making it possible to highlight one of these phenomena: * The radiographic periosteal reaction (or periosteal callus) defined by an opacity at the periphery of the fracture, corresponding to the first objectifiable calcification of the fracture hematoma and under the periosteum. * The secondary bone callus (or osteochondral) defined by a well-defined bone apposition of density close to that of the bone with opacification of the fracture line and union of the fracture site * Established remodeling activity when phenomena of axis correction, resorption of initial callus hypertrophy or re-permeabilizatio of the diaphyseal shaft can be demonstrated
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 3 inclusion and 6 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?
Define retrospectively the chronology of the appearance of periosteal callus, secondary callus and remodeling phenomena from the study of radiographs of the femur (time frame: Files analysed retrospectively from January 01, 2007 to December 31, 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 2 Nov 2023.