Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures
Primary Purpose
Scaphoid Bone Fracture Suspicion
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Scaphoid Bone Fracture Suspicion focused on measuring scaphoid, MRI, ESAOTE
Eligibility Criteria
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.
Sites / Locations
- Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI
Arm Description
MRI of the scaphoid bone fracture suspicion
Outcomes
Primary Outcome Measures
MRI and radiography interpretation items
comparaison between MRI and radiography interpretation items
Secondary Outcome Measures
Full Information
NCT ID
NCT01235806
First Posted
November 5, 2010
Last Updated
September 29, 2015
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01235806
Brief Title
Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures
Official Title
Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scaphoid Bone Fracture Suspicion
Keywords
scaphoid, MRI, ESAOTE
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI
Arm Type
Other
Arm Description
MRI of the scaphoid bone fracture suspicion
Intervention Type
Radiation
Intervention Name(s)
MRI
Intervention Description
MRI of the scaphoid bone fracture suspicion
Primary Outcome Measure Information:
Title
MRI and radiography interpretation items
Description
comparaison between MRI and radiography interpretation items
Time Frame
The day of the scaphoid fracture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas AMORETTI, MD
Organizational Affiliation
Medical and interventionnal Imaging Unit, Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures
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