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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01235806
First received: November 5, 2010
Last updated: December 8, 2011
Last verified: December 2011

November 5, 2010
December 8, 2011
March 2009
March 2009   (final data collection date for primary outcome measure)
MRI and radiography interpretation items [ Time Frame: The day of the scaphoid fracture ] [ Designated as safety issue: No ]
comparaison between MRI and radiography interpretation items
Same as current
Complete list of historical versions of study NCT01235806 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Scaphoid Bone Fracture Suspicion
Radiation: MRI
MRI of the scaphoid bone fracture suspicion
MRI
MRI of the scaphoid bone fracture suspicion
Intervention: Radiation: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2012
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Nicolas AMORETTI, MD amorettinicolas@yahoo.fr
France
 
NCT01235806
07-CPR-01
No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: Nicolas AMORETTI, MD Medical and interventionnal Imaging Unit, Nice University Hospital
Centre Hospitalier Universitaire de Nice
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP