Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children

August 27, 2010 updated by: Isfahan University of Medical Sciences

Study of Surgical Method Versus Casting for Treatment of Femoral Fracture in Children

The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is no consensus on treatment of closed femoral shaft fractures in children 6-12years old. We aimed to compare hip spica cast with titanium elastic nailing (TEN) in the treatment of femoral shaft fractures in children.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

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

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients 6-12 years old with femoral shaft fracture without exclusion criteria

Exclusion Criteria:

  • Segmental, Winquist type III and IV comminuted fractures, previously diagnosed neuromuscular disease (e.g., cerebral palsy), metabolic bone disorders (e.g. osteomalacia), or pathological fractures.

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: hip spica casting
Patients in the spica cast group treated with skeletal traction and spica cast applied for them
Device: Hip spica casting
we applied cast for three weeks in patients with femoral shaft fracture
Other Names:
  • TEN
Other: titanium elasting nailing
For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture
Procedure: titanium elastic nailing
we inserted titanium nail in femoral fractures retrogradely
Other Names:
  • TEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: at 1 months post-operatively
identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting
at 1 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time to walking with aids
Time Frame: at 1 months post-operatively
identification of the time to walking with aids in patients who treated with titanium elastic nailing or casting
at 1 months post-operatively
parent's satisfaction
Time Frame: at 1 months post-operatively
identification of parent's satisfaction with questionnair in patients who treated with titanium elastic nailing or casting
at 1 months post-operatively
the time absent from school
Time Frame: at 1 months post-operatively
identification of the time absent from school in patients who treated with titanium elasting nailing or casting
at 1 months post-operatively

Collaborators and Investigators

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

Sponsor

Isfahan University of Medical Sciences

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.

Helpful Links

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

February 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 27, 2010

First Posted (Estimate)

August 30, 2010

Study Record Updates

Last Update Posted (Estimate)

August 30, 2010

Last Update Submitted That Met QC Criteria

August 27, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASD-1213-5

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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