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

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

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.

Conditions studied

Lateral Condyle Fractures,Humerus,JakobⅡ Classification,Reduction

Browse trials for

Fractures, Bone 2,262

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.

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.

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.

What researchers measure

Primary outcomes

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

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

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.

Study locations

1 site

Shunyou Chen
Fuzhou, Fujian 350007, China

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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