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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01235806
Enrollment
36
Registered
2010-11-08
Start date
2009-03-31
Completion date
2012-03-31
Last updated
2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scaphoid Bone Fracture Suspicion

Keywords

scaphoid, MRI, ESAOTE

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.

Interventions

RADIATIONMRI

MRI of the scaphoid bone fracture suspicion

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MRI and radiography interpretation itemsThe day of the scaphoid fracturecomparaison between MRI and radiography interpretation items

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026