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

March 15, 2018 updated by: Shunyou Chen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350007
        • Shunyou Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Closed reduction
The children were treated with closed reduction.
Procedure: Closed reduction
The children were treated with closed reduction.
Open reduction
The children were treated with open reduction.
Procedure: Open reduction
The children were treated with Open reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic union
Time Frame: Up to 12 weeks.
Radiographic union in surgical treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.
Up to 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture displacement
Time Frame: Up to 12 weeks.
Fracture displacement in surgical treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.
Up to 12 weeks.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional clinical scores
Time Frame: Through study completion, an average of 1 year.
Dhillon scoring system for the outcome of the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shunyou Chen

Investigators

  • Study Director: Chen Shunyou, Phd, The Fuzhou No 2 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shunyou Chen

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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