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

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01190696
First received: August 27, 2010
Last updated: NA
Last verified: February 2009
History: No changes posted

August 27, 2010
August 27, 2010
February 2009
January 2010   (final data collection date for primary outcome measure)
Length of hospital stay [ Time Frame: at 1 months post-operatively ] [ Designated as safety issue: Yes ]
identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting
Same as current
No Changes Posted
  • the time to walking with aids [ Time Frame: at 1 months post-operatively ] [ Designated as safety issue: Yes ]
    identification of the time to walking with aids in patients who treated with titanium elastic nailing or casting
  • parent's satisfaction [ Time Frame: at 1 months post-operatively ] [ Designated as safety issue: Yes ]
    identification of parent's satisfaction with questionnair in patients who treated with titanium elastic nailing or casting
  • the time absent from school [ Time Frame: at 1 months post-operatively ] [ Designated as safety issue: Yes ]
    identification of the time absent from school in patients who treated with titanium elasting nailing or casting
Same as current
Not Provided
Not Provided
 
Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Femoral Shaft Fracture
  • Procedure: titanium elastic nailing
    we inserted titanium nail in femoral fractures retrogradely
    Other Name: TEN
  • Device: Hip spica casting
    we applied cast for three weeks in patients with femoral shaft fracture
    Other Name: TEN
  • hip spica casting
    Patients in the spica cast group treated with skeletal traction and spica cast applied for them
    Intervention: Device: Hip spica casting
  • titanium elasting nailing
    For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture
    Intervention: Procedure: titanium elastic nailing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01190696
ASD-1213-5
Yes
Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Not Provided
Study Chair: hamidreza shemshaki, MD MD,research comittee
Isfahan University of Medical Sciences
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP