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Completed

NCT Number: NCT01235806

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI

Radiation

MRI of the scaphoid bone fracture suspicion

Primary outcomes

  1. MRI and radiography interpretation items

    Time frame: The day of the scaphoid fracture

    comparaison between MRI and radiography interpretation items

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2012
First posted
Nov 8, 2010
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.