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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ER-spine trauma | patients with spinal trauma, who initially visits in emergency room |
| |
| OUT-spine trauma | patients with spinal trauma, who initially visits in outpatient clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NC-MRI, CE-MRI | Other | non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate (%) of change of treatment option between non-surgery vs. surgery, after review of enhanced MRI finding, compared with non-enhanced MRI only | 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 |
| Confidence level | 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 | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of non-enhanced and enhanced MRI | 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) | 2 months |
| Inter- and intra-reader agreement of confidence level |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic value of enhanced MRI | 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 | 2 months |
Inclusion Criteria:
Exclusion Criteria:
Relative contraindication of MR contrast
Patients impossible with follow-up period of at least 2 months clinically
Patients with severely impaired renal function of estimated glomerular filtration rate (GFR) < 30 mL/min/1.73m2 and/or on dialysis
patients with age less than 19 years
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300 patients that fulfilled the following criteria
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| Name | Affiliation | Role |
|---|---|---|
| Guen Young Lee, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guen Young Lee | Seongnam-si | Gyenggi-do | 463-707 | South Korea | ||
| Seoul National University Bundang Hospital |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Inter- and intra-reader agreement of confidence level between non-enhanced and enhanced MRI |
| 2 months |
| The rate (%) of change of treatment plan |
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 |
| 2 months |
| Seongnam-si |
| Gyeonggi-do |
| 763-707 |
| South Korea |