Long Term Follow up in Pediatric Supracondylar Humeral Fr... | NCT05780398

Studies
Long Term Follow up in Pediatric Supracondylar Humeral Fracture

NCT05780398

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Mar 22, 2023Actual

Enrollment

634Estimated

Phase

Not provided

Conditions

Supracondylar Humerus Fracture
Elbow Fracture

Interventions

Not provided

Countries

Not provided

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2023Estimated

Primary Completion Date

Jan 2024Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Mar 4, 2023

First Submission Date that Met QC Criteria

Mar 20, 2023

First Posted Date

Mar 22, 2023Actual

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

Mar 20, 2023

Last Update Posted Date

Mar 22, 2023Actual

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

The goal of this clinical trial is to learn about long term outcomes in Supracondylar Humeral Fracture in children after surgery.

The main questions it aims to answer are:

how good is the elbow function
what are the post-operative complication
what is the time before return to sport
what is the aesthetic prejudice of the scar for the patient Participants will answer questionnaries and send photographs of their elbows to the examinator

Detailed Description

Elbow fractures represent 5% of total fracture in children. Supracondylar humeral fractures compound half of them.

As distal humerus is responsible for only 20% of humeral growth, bone remodelage her is less important compared to other sites in children..

Many different attitudes are possible : orthopedic reduction, open reduction, percutaneous pinning ... No methode as clearly demontrated a superiority.

Percutaneous pinning as been widely used the last years though We haven't find any study evaluating long term outcomes regarding functionnal and aesthetic outcomes in supracondylar humeral fracture treated by percutaneous pinning.

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

634Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
functional outcome after supracondylar humeral fracture	Pediatric-Adolescent Shoulder and Elbow Survey (PEDI ASES), rate from 0 to 84, 0 is poor and 84 is excellent	1 day
functional outcome after supracondylar humeral fracture	FLYNN'S CRITERIA	1 day
functional outcome after supracondylar humeral fracture	range of motion mesured in degrees	1 day

Secondary Outcomes

Measure	Description	Time Frame
post operative complication	identify number and type of complication	1 day
time before return to sport	time in days before return to sport

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children operated for a supracondylar humeral fracture in university hospital of Grenoble from July 2011 to December 2019

Exclusion Criteria:

Opposition from patient or parents to participate
Children who did not effectively suffered a supracondylar humeral fracture

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children operated for a supracondylar humeral fracture in university hospital of Grenoble from July 2011 to December 2019

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000092482	Elbow Fractures

Ancestor Terms

ID	Term
D000092464	Elbow Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided