Scaphoid Bone Fracture Suspicion Clinical Trial
Official title:
Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures.
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Medical and Interventionnal Imaging Unit, Archet 2, Nice University Hospital | Nice |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nice |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MRI and radiography interpretation items | comparaison between MRI and radiography interpretation items | The day of the scaphoid fracture | No |