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

Recruiting

• Conditions: EOS

• Registration Number: NCT06245993
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-15
• Status Verified: 2024-01
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
absence of lower limb overgrowth	3 years	Leg Length Discrepancy in EOS imaging

Secondary Outcome Measures

Name	Time	Method
Measurement of the angle on the lower limb sagittal axis	3 years	Measurement of the angle on the sagittal axis of the lower limb 3 years after the end of treatment
Measurement of the angle on the lower limb on the frontal axis	3 years	Measurement of the angle on the femoral torsion of the lower limb 3 years after the end of treatment

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France