Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture (PFNF)

February 21, 2018 updated by: Shunyou Chen, The Fuzhou No 2 Hospital

An Multicenter Prospective Observational Study to Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture (Delbet Type II and III)

The purpose of this study is to compare the early postoperative radiologic and clinical outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck fracture (Delbet type II and Delbet type III).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The children aged 3 to 14 years with femoral neck fracture that were treated with pediatric hip plate and cannulated screw fixation.

Study Type

Observational

Enrollment (Actual)

30

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

3 years to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

pediatric femoral neck fracture(Delbet type II and Delbet type III)

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
Pediatric hip plate
The children were treated with pediatric hip plate.
Procedure: Pediatric hip plate
Children were treated with pediatric hip plate.
Cannulated screw
The children were treated with cannulated screw.
Procedure: Cannulated screw
Children were treated with cannulated screw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic union
Time Frame: Through study completion, an average of 0.5 year.
The time of radiographic union.
Through study completion, an average of 0.5 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Ratliff classification standard score
Time Frame: Through study completion, an average of 1 year.
Ratliff classification standard score was administered to determine the pain, function, activity and radiographic change.
Through study completion, an average of 1 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The complication
Time Frame: Through study completion, an average of 1 year.
The complication was evaluated by osteonecrosis, epiphyseal arrest, premature physeal closure, limb length discrepancy (over 3 cm) and internal fixation failure.
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

The Fuzhou No 2 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2016

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (ESTIMATE)

June 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • schen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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