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

NCT ID: NCT01235806

Last Updated: 2015-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-03-31

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.

Conditions

Scaphoid Bone Fracture Suspicion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MRI

MRI of the scaphoid bone fracture suspicion

Group Type: OTHER

MRI

Intervention Type: RADIATION

MRI of the scaphoid bone fracture suspicion

Interventions

MRI

MRI of the scaphoid bone fracture suspicion

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas AMORETTI, MD

Role: PRINCIPAL_INVESTIGATOR

Medical and interventionnal Imaging Unit, Nice University Hospital

Locations

Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital

Nice, , France

Countries

France

Other Identifiers

07-CPR-01

Identifier Type: -

Identifier Source: org_study_id