Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children
This study has been completed.
Sponsor:
Isfahan University of Medical Sciences
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
| Tracking Information | |||||
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| First Received Date ICMJE | August 27, 2010 | ||||
| Last Updated Date | August 27, 2010 | ||||
| Start Date ICMJE | February 2009 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children | ||||
| Official Title ICMJE | Study of Surgical Method Versus Casting for Treatment of Femoral Fracture in Children | ||||
| Brief Summary | 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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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Femoral Shaft Fracture | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 46 | ||||
| Completion Date | January 2010 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01190696 | ||||
| Other Study ID Numbers ICMJE | ASD-1213-5 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences | ||||
| Study Sponsor ICMJE | Isfahan University of Medical Sciences | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Isfahan University of Medical Sciences | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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