EOSFRAFEMKIDNCT06245993
Study of Residuals Deformities After Diaphyseal Femoral Fracture in Children Treated by Skin Traction
An observational study of EOS, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Diaphyseal femoral fracture in children <6 years old are treated by the skin traction technique. As demonstrated by numerous studies, given the significant potential for bone remodeling in young children, remodeling (excluding rotational disorder) allows anatomical correction. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- EOS
- What is being tested?
- EOS imaging
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Diaphyseal femoral fracture in children <6 years old are treated by the skin traction. The children have a Clinical examination and EOS imaging 3 years after skin traction treatment for femoral shaft fracture.
Who may be able to join
- <6 years old at the time of the fracture
- treatment by skin zenith traction
- femoral shaft fracture, traumatic, unilateral
Who cannot join
- Multiple fracture
- pathological fracture
- history of lower limb fracture
- contraindication to zenith traction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Céline Klein, MD, (33)322087571, klein.celine@chu-emaine.fr
About this study
Diaphyseal femoral fracture in children <6 years old are treated by the skin traction technique. As demonstrated by numerous studies, given the significant potential for bone remodeling in young children, remodeling (excluding rotational disorder) allows anatomical correction. The aim of this study is to confirm, via EOS imaging, the absence of residual deformities 3 years after the end of treatment in children treated in Amiens hospital department.
- Conditions
- EOS
- Being tested
- EOS imaging
- Keywords
- EOS, skin traction, femoral fracture, remodeling, leg length
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS imagingOther
EOS imaging 3 years after skin traction treatment for femoral shaft fracture.
| Study group | Role | What they receive |
|---|---|---|
| Diaphyseal femoral fracture treated children | Not described Receives: Other: EOS imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
absence of lower limb overgrowth
Leg Length Discrepancy in EOS imaging
Measured: 3 years
Secondary outcomes (3)
Measurement of the angle on the lower limb sagittal axis
Measurement of the angle on the sagittal axis of the lower limb 3 years after the end of treatment
Measured: 3 years
Measurement of the angle on the lower limb on the frontal axis
Measurement of the angle on the frontal axis of the lower limb 3 years after the end of treatment
Measured: 3 years
Measurement of the angle on the lower limb on the frontal axis
Measurement of the angle on the femoral torsion of the lower limb 3 years after the end of treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start15 Dec 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EOSStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Prospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245993
- Sponsor's protocol ID
- PI2023_843_0060
- Acronym
- FRAFEMKID
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Residuals Deformities After Diaphyseal Femoral Fracture in Children Treated by Skin Traction
- ClinicalTrials.gov ID
- NCT06245993
- Acronym / sponsor ID
- FRAFEMKID / PI2023_843_0060
- Conditions
- EOS
- Keywords
- EOS, skin traction, femoral fracture, remodeling, leg length
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Feb 2024 (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.
Diaphyseal femoral fracture in children <6 years old are treated by the skin traction technique. As demonstrated by numerous studies, given the significant potential for bone remodeling in young children, remodeling (excluding rotational disorder) allows anatomical correction. The aim of this study is to confirm, via EOS imaging, the absence of residual deformities 3 years after the end of treatment in children treated in Amiens hospital department.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diaphyseal femoral fracture treated children | – | Other: EOS imaging |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Diaphyseal femoral fracture in children <6 years old are treated by the skin traction. The children have a Clinical examination and EOS imaging 3 years after skin traction treatment for femoral shaft fracture.
Key inclusion criteria (3 listed)
- <6 years old at the time of the fracture
- treatment by skin zenith traction
- femoral shaft fracture, traumatic, unilateral
Key exclusion criteria (4 listed)
- Multiple fracture
- pathological fracture
- history of lower limb fracture
- contraindication to zenith traction
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 |
|---|---|---|
| EOS imagingEOS imaging 3 years after skin traction treatment for femoral shaft fracture. | Other | Diaphyseal femoral fracture treated children |
Primary outcome
absence of lower limb overgrowth
Time frame: 3 years
Leg Length Discrepancy in EOS imaging
3 secondary outcomes
Measurement of the angle on the lower limb sagittal axis
Time frame: 3 years
Measurement of the angle on the lower limb on the frontal axis
Time frame: 3 years
Measurement of the angle on the lower limb on the frontal axis
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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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.
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 EOS, run by Centre Hospitalier Universitaire, Amiens 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 4 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: looking for participants now, as of the sponsor's last update on 7 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact celine Klein, Pr ((33)322087571, klein.celine@chu-picardie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absence of lower limb overgrowth (time frame: 3 years). 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 7 Feb 2024.