Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Scaphoid Bone Fracture Suspicion |
Radiation: MRI |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures. |
- 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
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | January 2012 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
MRI
MRI of the scaphoid bone fracture suspicion
|
Radiation: MRI
MRI of the scaphoid bone fracture suspicion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Nicolas AMORETTI, MD | amorettinicolas@yahoo.fr |
| France | |
| Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital | Recruiting |
| Nice, France, 06000 | |
| Contact: Nicolas Amoretti, MD amorettinicolas@yahoo.fr | |
| Principal Investigator: Nicolas AMORETTI, MD | |
| Principal Investigator: | Nicolas AMORETTI, MD | Medical and interventionnal Imaging Unit, Nice University Hospital |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT01235806 History of Changes |
| Other Study ID Numbers: | 07-CPR-01 |
| Study First Received: | November 5, 2010 |
| Last Updated: | December 8, 2011 |
| Health Authority: | France: Direction Générale de la Santé France: French Data Protection Authority France: Institutional Ethical Committee |
Keywords provided by Centre Hospitalier Universitaire de Nice:
|
scaphoid MRI ESAOTE |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013