NCT06245993

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Dec 2023Dec 2027

Study Start

First participant enrolled

December 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 7, 2024

Status Verified

January 1, 2024

Enrollment Period

4 years

First QC Date

January 30, 2024

Last Update Submit

January 30, 2024

Conditions

EOS

Keywords

EOSskin tractionfemoral fractureremodelingleg length

Outcome Measures

Primary Outcomes (1)

  • absence of lower limb overgrowth

    Leg Length Discrepancy in EOS imaging

    3 years

Secondary Outcomes (3)

  • Measurement of the angle on the lower limb sagittal axis

    3 years

  • Measurement of the angle on the lower limb on the frontal axis

    3 years

  • Measurement of the angle on the lower limb on the frontal axis

    3 years

Study Arms (1)

Diaphyseal femoral fracture treated children

Other: EOS imaging

Interventions

EOS imagingOTHER

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

Diaphyseal femoral fracture treated children

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Central Study Contacts

celine Klein, Pr

CONTACT

(33)322087571klein.celine@chu-picardie.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

December 15, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 7, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)