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

Phase 2

Completed

• Conditions: Femoral Shaft Fracture
• Interventions: Device: Hip spica casting; Procedure: titanium elastic nailing

• Registration Number: NCT01190696
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

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 Timeline

• Status Verified: 2009-02
• Study Start: 2009-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-08-27
• Study First Submitted QC: 2010-08-27
• Last Update Submitted: 2010-08-27
• Study First Posted: 2010-08-30
• Last Update Posted: 2010-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hip spica casting	Hip spica casting	Patients in the spica cast group treated with skeletal traction and spica cast applied for them
titanium elasting nailing	titanium elastic nailing	For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	at 1 months post-operatively	identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Al-zahra university hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of