Study of Residuals Deformities After Diaphyseal Femoral F... | NCT06245993

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

NCT06245993

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Recruiting

Last Update Posted

Feb 7, 2024Actual

Enrollment

53Estimated

Phase

Not provided

Conditions

Interventions

EOS imaging

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2023Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Jan 30, 2024

First Submission Date that Met QC Criteria

Jan 30, 2024

First Posted Date

Feb 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2024

Last Update Posted Date

Feb 7, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diaphyseal femoral fracture treated children			Other: EOS imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EOS imaging	Other	EOS imaging 3 years after skin traction treatment for femoral shaft fracture.	Diaphyseal femoral fracture treated children

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Measurement of the angle on the lower limb sagittal axis	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Years

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
celine Klein, Pr	Contact	(33)322087571		klein.celine@chu-picardie.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens	Recruiting	Amiens		80054	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005264	Femoral Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided