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NCT05780398 Clinical Trial

Long Term Follow up in Pediatric Supracondylar Humeral Fracture

Elbow Fracture Clinical Trial

— SUPCONFOLLOW  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05780398
Other study ID # 38RC22.0384
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2023
Est. completion date October 2024

Study information
Verified date March 2023
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 634
Est. completion date October 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Grenoble

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary functional outcome after supracondylar humeral fracture FLYNN'S CRITERIA 1 day
Primary functional outcome after supracondylar humeral fracture range of motion mesured in degrees 1 day
Secondary post operative complication identify number and type of complication 1 day
Secondary time before return to sport time in days before return to sport 1 day
Secondary aesthetical prejudice The Patient and Observer Scar Assement Scale (POSAS), rate from 7 to 70, 7 is excellent and 70 is poor 1 day
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