Ignite Creation Date:
2024-05-06 @ 9:19 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02950532
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2016-10-18
Brief Title:
Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures
Sponsor:
AO Clinical Investigation and Publishing Documentation
Organization:
AO Innovation Translation Center
Study Overview
Official Title:
Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures T11-L2 A Diagnostic Test Study to Analyze Sensitivity and Specificity
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAM
Brief Summary:
The objective of this investigation is to confirm the results obtained in a pilot study showing that certain radiological parameters based on computed tomography CT scans seem to reliably detect posterior ligament complex PLC injury without the need for Magnetic Resonance Imaging MRI
Detailed Description:
Integrity of posterior ligament complex PLC has an important bearing on the treatment strategies for thoracolumbar TL fractures Magnetic Resonance Imaging MRI is the gold standard to confirm PLC injury The routine use of MRI has its limitations especially since in most trauma centers MRI is not the primary assessment for TL fractures due to reduced availability increased cost and its adverse applicability in trauma setting and in case of a polytrauma In contrast computed tomography CT scans are an integral part of trauma evaluation protocols are accurate in spine fracture diagnosis and are performed in less time making them suitable to assess polytrauma scenarios In a recent pilot study a number of radiological parameters based on CT scans have shown to reliably detect PLC injury when compared to MRI The aim of the study is to reconfirm and validate these CT based parameters to assess PLC injury compared to MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None