Long Term Follow up in Pediatric Supracondylar Humeral Fracture (SUPCONFOLLOW)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Elbow Fracture; Supracondylar Humerus 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 Type: Observational
• Enrollment (Anticipated): 634

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	1 day
aesthetical prejudice	The Patient and Observer Scar Assement Scale (POSAS), rate from 7 to 70, 7 is excellent and 70 is poor	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: March 4, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: long term follow up
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: 38RC22.0384

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No