CompletedNCT07265310Updated Dec 4, 2025

Pre-therapeutic Value of Emergency Spine MRI in Patients With Thoraco-lumbar Spine Injuries - A Prospective Study.

An observational study in Spinal Fracture, Spinal Injuries and Wounds and Injuries, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 150
Ages: 18 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Spinal Fracture
Spinal Injuries
Wounds and Injuries

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In context

Spinal Fractures

144 studies on the registry are indexed under Spinal Fractures; 24 are open to participants now.

This study's enrollment of 150 is above the median of 93 across 55 observational studies indexed under Spinal Fractures.

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Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Adults admitted in the emergency departement of the university hospital of Nice, France.

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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

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 design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 150 participants (actual)
Patient registry: No

Interventions

ProcedureClinical 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.

What researchers measure

Primary outcomes

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)
Time frame: At the inclusion

Secondary outcomes

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.
Time frame: At the inclusion
Change in AO spine classification
Comparison of CT scan and MRI AO spine classification of injuries.
Time frame: At the inclusion

Study locations

1 site

CHU de France
Nice, Alpes Maritimes 06000, France

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2023 to primary completion in Sep 2025, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 24, 2025
First posted: Dec 4, 2025
StartActual: Nov 1, 2023
Primary completionActual: Sep 30, 2025
CompletionActual: Sep 30, 2025
Last update: Dec 4, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07265310
Lead sponsor: Centre Hospitalier Universitaire de Nice
Responsible party: Sponsor
First posted: Dec 4, 2025
Start date: Nov 1, 2023
Primary completion: Sep 30, 2025
Completion: Sep 30, 2025
Last update: Dec 4, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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