- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07265310
Pre-therapeutic Value of Emergency Spine MRI in Patients With Thoraco-lumbar Spine Injuries - A Prospective Study.
November 24, 2025 updated by: Centre Hospitalier Universitaire de Nice
The main objective is to determine whether the realisation of an emergency spine MRI in addition to CT-scan( Computed Tomography) in patients with thoraco-lumbar spine injuries changes the therapeutic management.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alpes Maritimes
-
Nice, Alpes Maritimes, France, 06000
- CHU de France
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Adults admitted in the emergency departement of the university hospital of Nice, France.
Description
Inclusion Criteria:
- Adults aged > 18 years old admitted in the emergency department for a thoracolumbar spine trauma, who have undergone a ct scan and a mri of the spine.
Exclusion Criteria:
- Underlying pathology of the spine, AO spine A0 and AO spine C traumas, neurological symptoms or clinical examination not done for any reason.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in therapeutic management of thoraco-lumbar spine injuries
Time Frame: At the inclusion
|
The Bowker test will be used to analyze paired categorical data and determine whether there is symmetry between the rows and columns of a square table (3x3; before/after MRI)
|
At the inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occult fractures
Time Frame: At the inclusion
|
Account of fractures only viewed with MRI, defined as T1 hyposignal and T2 STIR (short TI inversion recovery .hypersignal of a vertebral endplate.
|
At the inclusion
|
|
Change in AO spine classification
Time Frame: At the inclusion
|
Comparison of CT scan and MRI AO spine classification of injuries.
|
At the inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
November 24, 2025
First Submitted That Met QC Criteria
November 24, 2025
First Posted (Estimated)
December 4, 2025
Study Record Updates
Last Update Posted (Estimated)
December 4, 2025
Last Update Submitted That Met QC Criteria
November 24, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25Radio02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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