NCT05780398

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
634

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

March 4, 2023

Last Update Submit

March 20, 2023

Conditions

Supracondylar Humerus FractureElbow Fracture

Keywords

long term follow up

Outcome Measures

Primary Outcomes (3)

  • 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 (3)

  • post operative complication

    1 day

  • time before return to sport

    1 day

  • aesthetical prejudice

    1 day

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Elbow Fractures

Condition Hierarchy (Ancestors)

Elbow InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2023

First Posted

March 22, 2023

Study Start

March 1, 2023

Primary Completion

January 1, 2024

Study Completion

October 1, 2024

Last Updated

March 22, 2023

Record last verified: 2023-03