Back to resultsTitanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children
Primary Purpose
Femoral Shaft Fracture
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
titanium elastic nailing
Hip spica casting
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Shaft Fracture focused on measuring Spica Cast, TEN, Femoral Shaft Fracture, Children
Eligibility 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.
Sites / Locations
- Al-zahra university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
hip spica casting
titanium elasting nailing
Arm Description
Patients in the spica cast group treated with skeletal traction and spica cast applied for them
For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture
Outcomes
Primary Outcome Measures
Length of hospital stay
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
identification of the time to walking with aids in patients who treated with titanium elastic nailing or casting
parent's satisfaction
identification of parent's satisfaction with questionnair in patients who treated with titanium elastic nailing or casting
the time absent from school
identification of the time absent from school in patients who treated with titanium elasting nailing or casting
Full Information
NCT ID
NCT01190696
First Posted
August 27, 2010
Last Updated
August 27, 2010
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01190696
Brief Title
Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children
Official Title
Study of Surgical Method Versus Casting for Treatment of Femoral Fracture in Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Shaft Fracture
Keywords
Spica Cast, TEN, Femoral Shaft Fracture, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hip spica casting
Arm Type
Other
Arm Description
Patients in the spica cast group treated with skeletal traction and spica cast applied for them
Arm Title
titanium elasting nailing
Arm Type
Other
Arm Description
For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture
Intervention Type
Procedure
Intervention Name(s)
titanium elastic nailing
Other Intervention Name(s)
TEN
Intervention Description
we inserted titanium nail in femoral fractures retrogradely
Intervention Type
Device
Intervention Name(s)
Hip spica casting
Other Intervention Name(s)
TEN
Intervention Description
we applied cast for three weeks in patients with femoral shaft fracture
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting
Time Frame
at 1 months post-operatively
Secondary Outcome Measure Information:
Title
the time to walking with aids
Description
identification of the time to walking with aids in patients who treated with titanium elastic nailing or casting
Time Frame
at 1 months post-operatively
Title
parent's satisfaction
Description
identification of parent's satisfaction with questionnair in patients who treated with titanium elastic nailing or casting
Time Frame
at 1 months post-operatively
Title
the time absent from school
Description
identification of the time absent from school in patients who treated with titanium elasting nailing or casting
Time Frame
at 1 months post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamidreza shemshaki, MD
Organizational Affiliation
MD,research comittee
Official's Role
Study Chair
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.mui.ac.ir
Description
(Isfahan university of medical science)
Learn more about this trial
Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children
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