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CompletedNCT03447496JCHLCFUpdated Mar 19, 2018

Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children

An observational study in Lateral Condyle Fractures,Humerus,JakobⅡ Classification,Reduction, sponsored by Shunyou Chen. Completed at 1 site in China. Open to participants aged Up to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-19.

Sponsored by Shunyou Chen · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
Up to 14 Years
Sex
All
01

Study summary

Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.

Read the detailed description

The Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children that were treated with closed or open reduction.

02

Conditions studied

  • Lateral Condyle Fractures,Humerus,JakobⅡ Classification,Reduction

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03

In context

Humeral Fractures

106 studies on the registry are indexed under Humeral Fractures; 20 are open to participants now.

This study's enrollment of 100 is close to the median of 91 across 36 observational studies indexed under Humeral Fractures.

Browse Humeral Fractures studies →

Lead sponsor

This is the only study on the registry with Shunyou Chen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study.

Exclusion criteria

Exclusion Criteria:

  • Pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Closed reduction

    The children were treated with closed reduction.

    Procedure: Closed reduction

  • Open reduction

    The children were treated with open reduction.

    Procedure: Open reduction

Interventions

  • ProcedureClosed reduction

    The children were treated with closed reduction.

  • ProcedureOpen reduction

    The children were treated with Open reduction.

06

What researchers measure

Primary outcomes

  1. Radiographic union

    Radiographic union in surgical treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.

    Time frame: Up to 12 weeks.

Secondary outcomes

  1. Fracture displacement

    Fracture displacement in surgical treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.

    Time frame: Up to 12 weeks.

Other outcomes

  1. Functional clinical scores

    Dhillon scoring system for the outcome of the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.

    Time frame: Through study completion, an average of 1 year.

07

Study locations

1 site
  • Shunyou Chen
    Fuzhou, Fujian 350007, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Jan 2018, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2018
First posted
Feb 27, 2018
StartActual
Jan 1, 2018
Primary completionActual
Jan 1, 2018
CompletionActual
Jan 1, 2018
Last update
Mar 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03447496
Lead sponsor
Shunyou Chen
Responsible party
Shunyou Chen (Director,Head of Orthopaedics, The Fuzhou No 2 Hospital) — Sponsor-investigator
First posted
Feb 27, 2018
Start date
Jan 1, 2018
Primary completion
Jan 1, 2018
Completion
Jan 1, 2018
Last update
Mar 19, 2018

Study contacts

Chen Shunyou, Phd
study director · The Fuzhou No 2 Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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