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Completed

NCT Number: NCT01190696

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

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

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Key information

Conditions

Femoral Shaft Fracture

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al-zahra university hospital

Isfahan, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

titanium elastic nailing

Procedure

we inserted titanium nail in femoral fractures retrogradely

Other names: TEN

Hip spica casting

Device

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

Other names: TEN

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 30, 2010
Registry last updated
Aug 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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