Spinal FractureNCT07265310
Pre-therapeutic Value of Emergency Spine MRI in Patients With Thoraco-lumbar Spine Injuries - A Prospective Study.
An observational study of Spinal Fracture and Spinal Injuries, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Fracture, Spinal Injuries, Wounds and Injuries
- What is being tested?
- Clinical value of spine MRI in therapeutic management of patients admitted for thoraco-lumbar spine injuries, in addition to ct-scan.
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults admitted in the emergency departement of the university hospital of Nice, France.
Who may be able to join
- 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.
Who cannot join
- Underlying pathology of the spine, AO spine A0 and AO spine C traumas, neurological symptoms or clinical examination not done for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinal Fracture, Spinal Injuries, Wounds and Injuries
- Being tested
- Clinical value of spine MRI in therapeutic management of patients admitted for thoraco-lumbar spine injuries, in addition to ct-scan.
- Medical subject headings
- Spinal Fractures, Spinal Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical value of spine MRI in therapeutic management of patients admitted for thoraco-lumbar spine injuries, in addition to ct-scan.Procedure or surgery
Therapeutic possibilities include conservative, percutaneous and invasive (surgery) treatments. The aim of the study is to evaluate whether spine mri changes the therapeutic management.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in therapeutic management of thoraco-lumbar spine injuries
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)
Measured: At the inclusion
Secondary outcomes (2)
Occult fractures
Account of fractures only viewed with MRI, defined as T1 hyposignal and T2 STIR (short TI inversion recovery .hypersignal of a vertebral endplate.
Measured: At the inclusion
Change in AO spine classification
Comparison of CT scan and MRI AO spine classification of injuries.
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Nov 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FractureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265310
- Sponsor's protocol ID
- 25Radio02
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-therapeutic Value of Emergency Spine MRI in Patients With Thoraco-lumbar Spine Injuries - A Prospective Study.
- ClinicalTrials.gov ID
- NCT07265310
- Acronym / sponsor ID
- 25Radio02
- Conditions
- Spinal Fracture, Spinal Injuries, Wounds and Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults admitted in the emergency departement of the university hospital of Nice, France.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Underlying pathology of the spine, AO spine A0 and AO spine C traumas, neurological symptoms or clinical examination not done for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical value of spine MRI in therapeutic management of patients admitted for thoraco-lumbar spine injuries, in addition to ct-scan.Therapeutic possibilities include conservative, percutaneous and invasive (surgery) treatments. The aim of the study is to evaluate whether spine mri changes the therapeutic management. | Procedure or surgery | – |
Primary outcome
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)
2 secondary outcomes
Occult fractures
Time frame: At the inclusion
Change in AO spine classification
Time frame: At the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fracture and Spinal Injuries, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in therapeutic management of thoraco-lumbar spine injuries (time frame: At the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.