NCT04582123

Brief Summary

The objective of this prospective randomized controlled trial is to evaluate and compare the outcome of the 2wire vs 3 wire crossed pin configurations in the management of supracondylar humeral fractures in children.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

5 years

First QC Date

October 5, 2020

Last Update Submit

October 5, 2020

Conditions

Supracondylar Humerus Fracture

Outcome Measures

Primary Outcomes (1)

  • functional outcome of two fixation techniques

    comparison of Flynn's criteria

    5 years

Study Arms (1)

comparison of two cross pin fixation methods

OTHER

Fixation of supracondylar humerus fractures with 2 crossed pins and 3 crossed pins are compared in terms of Flynn's criteria

Procedure: crossed pin configuration

Interventions

crossed pin configurationPROCEDURE

comparison of two crossed pin fixation methods

comparison of two cross pin fixation methods

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • Patients with Type I and Type II injuries, flexion type injuries, open fractures and patients above the age of 12 years were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 9, 2020

Study Start

January 15, 2015

Primary Completion

January 24, 2020

Study Completion

January 24, 2020

Last Updated

October 9, 2020

Record last verified: 2020-10