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NCT Number: NCT06245993

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

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.

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Key information

Conditions

EOS Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOS imaging

Other

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

Primary outcomes

  1. absence of lower limb overgrowth

    Time frame: 3 years

    Leg Length Discrepancy in EOS imaging

Secondary outcomes

  1. 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

  2. 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. 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

Study contacts

Contact information is provided by the study sponsor or research team.

celine Klein, Pr

CONTACT

[email protected]

(33)322087571

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: FRAFEMKID

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 7, 2024
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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