Trauma
Conditions
Keywords
spine, trauma, MRI, contrast
Brief summary
Non-contrast MRI with T2 fat suppression has been a useful imaging modality in evaluation spinal trauma. However, the role of contrast enhancement has not investigated in patients with spinal trauma. Therefore, this prospective study aims to evaluate the usefulness of contrast enhanced MRI for spinal trauma W/U clinically. The study hypothesis is that there is no additional gain in addition of contrast enhanced study to routine non-contrast MRI.
Interventions
OTHERNC-MRI, CE-MRI
non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI)
Sponsors
Bayer
Seoul National University Bundang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who provided the informed consent 2. Patients with spinal trauma 3. Patients with age of 19 years or more
Exclusion criteria
1. Relative contraindication of MR contrast * previous history of any adverse event after injection of magnetic resonance contrast * pregnant or breast-feeding state * within 2 weeks after liver transplantation * epileptic disorder 2. Patients impossible with follow-up period of at least 2 months clinically 3. Patients with severely impaired renal function of estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73m2 and/or on dialysis 4. patients with age less than 19 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only | 2 months | The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only |
| Confidence level | 2 months | Confidence level (1, definitely negative; 2, probably negative; 3, equivocal; 4, probably positive; 5, definitely positive) for lesion of spinal body, posterior compartment, soft tissue (posterior ligamentous complex of thoracolumbar spine and discoligamentous complex of cervical spine), spinal cord, and epidural/subdural hematoma/hemorrhage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of non-enhanced and enhanced MRI | 2 months | Diagnostic accuracy of non-enhanced and enhanced MRI in patients with operations for each anatomical lesion (e.g. fracture of body, fracture of posterior compartment, soft tissue injury, cord injury, and epidural/subdural hematoma) |
| Inter- and intra-reader agreement of confidence level | 2 months | Inter- and intra-reader agreement of confidence level between non-enhanced and enhanced MRI |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prognostic value of enhanced MRI | 2 months | Prognostic value of enhanced MRI, compared with non-enhanced MRI, based on clinical feature during follow-up period: TLICS(thoracolumbar injury classification and severity score) or SLIC(subaxial cervical injury classification system)score for non-surgery group vs. surgery group |
| The rate (%) of change of treatment plan | 2 months | The rate (%) of change of treatment plan between posterior vs. anterior vs. anterior & posterior approaches, after review of enhanced MRI finding, compared with non-enhanced MRI only |
Countries
South Korea
Outcome results
None listed