Study of Residuals Deformities After Diaphyseal Femoral Fracture in Children Treated by Skin Traction (FRAFEMKID)

January 30, 2024 updated by: Centre Hospitalier Universitaire, Amiens
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • <6 years old at the time of the fracture
  • treatment by skin zenith traction
  • femoral shaft fracture, traumatic, unilateral

Exclusion Criteria:

  • Multiple fracture
  • pathological fracture
  • history of lower limb fracture
  • contraindication to zenith traction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diaphyseal femoral fracture treated children
Other: EOS imaging
EOS imaging 3 years after skin traction treatment for femoral shaft fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
absence of lower limb overgrowth
Time Frame: 3 years
Leg Length Discrepancy in EOS imaging
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the angle on the lower limb sagittal axis
Time Frame: 3 years
Measurement of the angle on the sagittal axis of the lower limb 3 years after the end of treatment
3 years
Measurement of the angle on the lower limb on the frontal axis
Time Frame: 3 years
Measurement of the angle on the frontal axis of the lower limb 3 years after the end of treatment
3 years
Measurement of the angle on the lower limb on the frontal axis
Time Frame: 3 years
Measurement of the angle on the femoral torsion of the lower limb 3 years after the end of treatment
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Estimated)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2023_843_0060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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