Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures.

Conditions
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Scaphoid Bone Fracture Suspicion

Intervention / Treatment
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* Radiation: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical suspicion of scaphoid bone fracture, whatever the radiologic check-up result is. Major patient who signed the informed consent form. Patient affiliated to French national health and pensions organization. NON INCLUSION MRI contraindication. No pain. No traumatic antecedent. Pregnant or suckler women. Patient under a guardianship or a trusteeship Patient deprived of liberty consequently to a judiciary procedure Patient holding a pace-maker Patient holding a foreign body or ferromagnetic prosthetic material.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI<br>MRI of the scaphoid bone fracture suspicion | Radiation: MRI<br>* MRI of the scaphoid bone fracture suspicion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI and radiography interpretation items | comparaison between MRI and radiography interpretation items | The day of the scaphoid fracture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scaphoid, MRI, ESAOTE