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Recruiting NCT06245993

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

Observational EOS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EOS imaging.
Who it may be relevant to
Registry conditions: EOS. Basic parameters: up to 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other EOS imaging
    EOS imaging 3 years after skin traction treatment for femoral shaft fracture.

Primary outcome measures

  • absence of lower limb overgrowth [Time frame: 3 years]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • CHU Amiens — Amiens

Identifiers

NCT: NCT06245993 · PI2023_843_0060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗