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

Femoral Shaft Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190696
• Other study ID #: ASD-1213-5
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2010
• Last updated: August 27, 2010
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: February 2009
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Femoral Shaft Fracture
• Fractures, Bone

Intervention

Procedure:
• titanium elastic nailing
we inserted titanium nail in femoral fractures retrogradely

Device:
• Hip spica casting
we applied cast for three weeks in patients with femoral shaft fracture

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-zahra university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting	at 1 months post-operatively	Yes
Secondary	the time to walking with aids	identification of the time to walking with aids in patients who treated with titanium elastic nailing or casting	at 1 months post-operatively	Yes
Secondary	parent's satisfaction	identification of parent's satisfaction with questionnair in patients who treated with titanium elastic nailing or casting	at 1 months post-operatively	Yes
Secondary	the time absent from school	identification of the time absent from school in patients who treated with titanium elasting nailing or casting	at 1 months post-operatively	Yes

External Links

•   (Isfahan university of medical science)