NCT07265310

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
Last Updated

December 4, 2025

Status Verified

October 1, 2025

Enrollment Period

1.9 years

First QC Date

November 24, 2025

Last Update Submit

November 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    At the inclusion

Secondary Outcomes (2)

  • Occult fractures

    At the inclusion

  • Change in AO spine classification

    At the inclusion

Interventions

Therapeutic possibilities include conservative, percutaneous and invasive (surgery) treatments. The aim of the study is to evaluate whether spine mri changes the therapeutic management.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Underlying pathology of the spine, AO spine A0 and AO spine C traumas, neurological symptoms or clinical examination not done for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de France

Nice, Alpes Maritimes, 06000, France

Location

MeSH Terms

Conditions

Spinal FracturesSpinal InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Back InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 4, 2025

Study Start

November 1, 2023

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

December 4, 2025

Record last verified: 2025-10

Locations