NCT03447496

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
Last Updated

March 19, 2018

Status Verified

February 1, 2018

Enrollment Period

Same day

First QC Date

January 31, 2018

Last Update Submit

March 15, 2018

Conditions

Lateral Condyle Fractures,Humerus,JakobⅡ Classification,Reduction

Outcome Measures

Primary Outcomes (1)

  • Radiographic union

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

    Up to 12 weeks.

Secondary Outcomes (1)

  • Fracture displacement

    Up to 12 weeks.

Other Outcomes (1)

  • Functional clinical scores

    Through study completion, an average of 1 year.

Study Arms (2)

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

Closed reductionPROCEDURE

The children were treated with closed reduction.

Closed reduction
Open reductionPROCEDURE

The children were treated with Open reduction.

Open reduction

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shunyou Chen

Fuzhou, Fujian, 350007, China

Location

MeSH Terms

Interventions

Closed Fracture ReductionOpen Fracture Reduction

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Chen Shunyou, Phd

    The Fuzhou No 2 Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director,Head of Orthopaedics

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 27, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 19, 2018

Record last verified: 2018-02

Locations

CN(1)