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Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures (T11-L2): A Diagnostic Test Study to Analyze Sensitivity and Specificity
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)
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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
The 1st Affiliated Hospital of Zhejiang University
Hangzhou, China
Assiut Universtiy Hospitals
Asyut, Egypt
Ganga Hospital
Coimbatore, India
Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Royal Victoria Hospital
Belfast, United Kingdom
Start Date
October 1, 2016
Primary Completion Date
October 1, 2017
Completion Date
June 1, 2018
Last Updated
August 13, 2020
60
ACTUAL participants
Retrospective radiological evaluation
OTHER
Lead Sponsor
AO Clinical Investigation and Publishing Documentation
NCT04812730
NCT04885244
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT03839914