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

NCT01235806 | Completed

• 1 other identifier: 07-CPR-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

scaphoid; MRI; ESAOTE

Outcome Measures

Primary Outcomes (1)

• MRI and radiography interpretation items

  comparaison between MRI and radiography interpretation items

  The day of the scaphoid fracture

Study Arms (1)

MRI

OTHER

MRI of the scaphoid bone fracture suspicion

Radiation: MRI

Interventions

MRI RADIATION

MRI of the scaphoid bone fracture suspicion

MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical suspicion of scaphoid bone fracture, whatever the radiologic check-up result is.
• Major patient who signed the informed consent form.
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

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

Nice, 06000, France

Location

Study Officials

• Nicolas AMORETTI, MD

  Medical and interventionnal Imaging Unit, Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: March 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2012
• Last Updated: September 30, 2015

Record last verified: 2015-09

Locations

FR (1)