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

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ClinicalTrials.gov Identifier: NCT01190696
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : August 30, 2010
Sponsor:
Information provided by:
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.

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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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.

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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

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 Posted: August 30, 2010    Key Record Dates
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