Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption
This study has been completed.
Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00556010
First received: November 8, 2007
Last updated: July 19, 2012
Last verified: April 2011
| Tracking Information | |||||||||||||||||||||||||
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| First Received Date ICMJE | November 8, 2007 | ||||||||||||||||||||||||
| Last Updated Date | July 19, 2012 | ||||||||||||||||||||||||
| Start Date ICMJE | January 2009 | ||||||||||||||||||||||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00556010 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption | ||||||||||||||||||||||||
| Official Title ICMJE | Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption | ||||||||||||||||||||||||
| Brief Summary | Ankle fractures are common injuries that are being operated routinely. In order to restore the long term function and prevent arthritis of the ankle the broken fragments should be put in place precisely. Inadequate reduction can result in pain and long term disability. Recently, based on MRI studies and clinical studies, a significant number of ankle fractures are apparently fixed with less than optimal results. We suggest that the use of a new device that enables better three dimensional imaging will improve the quality of operations performed for ankle fractures. |
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| Detailed Description | Not Provided | ||||||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||||||||||||||
| Study Population | patients with fracture in the ankle with Syndesmosis disruption |
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| Condition ICMJE | Ankle Injuries | ||||||||||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||||||||||||||||||
| Completion Date | July 2011 | ||||||||||||||||||||||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 18 Years to 65 Years | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Location Countries ICMJE | Israel | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT00556010 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | WEIL-HMO-CTIL | ||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||
| Responsible Party | Not Provided | ||||||||||||||||||||||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||||||||||||||||||||||
| Verification Date | April 2011 | ||||||||||||||||||||||||
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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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