SUPCONFOLLOW: Long Term Follow up in Pediatric Supracondylar Humeral Fracture

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05780398

Collaborator

(none)

634

Enrollment

19.1

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Supracondylar Humerus Fracture Elbow Fracture

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

634 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Long Term Follow up in Pediatric Supracondylar Humeral Fracture After Surgical Treatment

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

post operative complication [1 day]
identify number and type of complication
time before return to sport [1 day]
time in days before return to sport
aesthetical prejudice [1 day]
The Patient and Observer Scar Assement Scale (POSAS), rate from 7 to 70, 7 is excellent and 70 is poor

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT05780398

Other Study ID Numbers:

38RC22.0384

First Posted:

Mar 22, 2023

Last Update Posted:

Mar 22, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Grenoble

long term follow up

Additional relevant MeSH terms:

Fractures, Bone

Humeral Fractures

Study Results

No Results Posted as of Mar 22, 2023