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

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

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.

Study Overview

• Status: Completed
• Conditions: Scaphoid Bone Fracture Suspicion
• Intervention / Treatment: Radiation: MRI

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MRI; MRI of the scaphoid bone fracture suspicion	Radiation: MRI; MRI of the scaphoid bone fracture suspicion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Nicolas AMORETTI, MD, Medical and interventionnal Imaging Unit, Nice University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 5, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Estimate): September 30, 2015
• Last Update Submitted That Met QC Criteria: September 29, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: MRI; scaphoid; ESAOTE
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 07-CPR-01