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

NCT ID: NCT01190696

Last Updated: 2010-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Femoral Shaft Fracture

Keywords

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Spica Cast TEN Femoral Shaft Fracture Children

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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hip spica casting

Patients in the spica cast group treated with skeletal traction and spica cast applied for them

Group Type OTHER

Hip spica casting

Intervention Type DEVICE

we applied cast for three weeks in patients with femoral shaft fracture

titanium elasting nailing

For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture

Group Type OTHER

titanium elastic nailing

Intervention Type PROCEDURE

we inserted titanium nail in femoral fractures retrogradely

Interventions

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titanium elastic nailing

we inserted titanium nail in femoral fractures retrogradely

Intervention Type PROCEDURE

Hip spica casting

we applied cast for three weeks in patients with femoral shaft fracture

Intervention Type DEVICE

Other Intervention Names

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TEN TEN

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Isfahan University of Medical Sciences

Principal Investigators

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hamidreza shemshaki, MD

Role: STUDY_CHAIR

MD,research comittee

Locations

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Al-zahra university hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

Other Identifiers

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ASD-1213-5

Identifier Type: -

Identifier Source: org_study_id