Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures
| Tracking Information | |||||
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| First Received Date ICMJE | November 5, 2010 | ||||
| Last Updated Date | December 8, 2011 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
MRI and radiography interpretation items [ Time Frame: The day of the scaphoid fracture ] [ Designated as safety issue: No ] comparaison between MRI and radiography interpretation items |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01235806 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 | Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures | ||||
| Official Title ICMJE | Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures. | ||||
| Brief Summary | The Alpes Maritimes county administration (France) equipped Nice University Hospital of a 0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the medical imaging unit. The aim of our project is to study its interest in diagnosis of scaphoid fractures. Conventional medical care for patients being suspected to have a scaphoid fracture consists in performing a clinical examination and a radiographic check-up with at least 4 incidences, which 2 specific incidences for the scaphoid bone. Yet, this check up is sometimes defective, causing false positives unnecessary immobilisation and false negatives delays in patient medical care, increasing the risk of complication. Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to professional reclassification. Alternative imaging exists, but is often irradiating, and never reaches the optimal specificity and sensitivity. MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of cases. The problem is the lack of accessibility for emergency cases; therefore there is a great interest in validating the use of a MRI dedicated to distal articulations. The few studies that study costs of diagnosis strategies including MRI in scaphoid bone fractures diagnosis show a reduction of medical costs if this technique is used early. Our project represents an essential initial step in evaluating the impact of a low field MRI dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will be a medico-economical study, since scaphoid fractures occur frequently. Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Scaphoid Bone Fracture Suspicion | ||||
| Intervention ICMJE | Radiation: MRI
MRI of the scaphoid bone fracture suspicion |
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| Study Arm (s) | MRI
MRI of the scaphoid bone fracture suspicion
Intervention: Radiation: MRI |
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | January 2012 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01235806 | ||||
| Other Study ID Numbers ICMJE | 07-CPR-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Centre Hospitalier Universitaire de Nice | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nice | ||||
| Verification Date | December 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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