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

Not Applicable

Completed

• Conditions: Scaphoid Bone Fracture Suspicion
• Interventions: Radiation: MRI

• Registration Number: NCT01235806
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-03
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-07
• Study Completion: 2012-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI	MRI	MRI of the scaphoid bone fracture suspicion

Primary Outcome Measures

Name	Time	Method
MRI and radiography interpretation items	The day of the scaphoid fracture	comparaison between MRI and radiography interpretation items

Trial Locations

Locations (1)

Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital; 🇫🇷 Nice, France