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

NCT01235806 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-09-30

No results posted yet for this study

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

Interventions

RADIATION

MRI

MRI of the scaphoid bone fracture suspicion

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Nicolas AMORETTI, MD · Medical and interventionnal Imaging Unit, Nice University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-03-31
Completion
2012-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01235806 on ClinicalTrials.gov