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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01190696
First Posted: August 30, 2010
Last Update Posted: August 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Isfahan University of Medical Sciences
  Purpose
The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.

Condition Intervention Phase
Femoral Shaft Fracture Procedure: titanium elastic nailing Device: Hip spica casting Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Surgical Method Versus Casting for Treatment of Femoral Fracture in Children

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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

  • 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


Enrollment: 46
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
hip spica casting
Patients in the spica cast group treated with skeletal traction and spica cast applied for them
Device: Hip spica casting
we applied cast for three weeks in patients with femoral shaft fracture
Other Name: TEN
titanium elasting nailing
For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture
Procedure: titanium elastic nailing
we inserted titanium nail in femoral fractures retrogradely
Other Name: TEN

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190696


Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: hamidreza shemshaki, MD MD,research comittee
  More Information

Additional Information:
Responsible Party: Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01190696     History of Changes
Other Study ID Numbers: ASD-1213-5
First Submitted: August 27, 2010
First Posted: August 30, 2010
Last Update Posted: August 30, 2010
Last Verified: February 2009

Keywords provided by Isfahan University of Medical Sciences:
Spica Cast
TEN
Femoral Shaft Fracture
Children

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries


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