Evaluation of Usefulness of Contrast Enhanced MRI in Evaluation of Spine Trauma: Prospective Study

Completed

• Conditions: Trauma
• Interventions: Other: NC-MRI, CE-MRI

• Registration Number: NCT01880944
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-19
• Study Start: 2013-06-24
• Primary Completion: 2016-12-14
• Study Completion: 2017-02-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-03
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patients who provided the informed consent
2. Patients with spinal trauma
3. Patients with age of 19 years or more

Read 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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OUT-spine trauma	NC-MRI, CE-MRI	patients with spinal trauma, who initially visits in outpatient clinic
ER-spine trauma	NC-MRI, CE-MRI	patients with spinal trauma, who initially visits in emergency room

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Inter- and intra-reader agreement of confidence level	2 months	Inter- and intra-reader agreement of confidence level between non-enhanced and enhanced MRI
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)

Trial Locations

Locations (2)

Guen Young Lee; 🇰🇷 Seongnam-si, Gyenggi-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of