NCT02950532

Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures

Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures (T11-L2): A Diagnostic Test Study to Analyze Sensitivity and Specificity

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Deformity
• Spinal Fractures
• Spinal Injuries
• Kyphosis

Interventions

Type	Name	Description
OTHER	Retrospective radiological evaluation	Radiological evaluation will be performed in already existing imaging exams. Superior-inferior end plate angle (SIEA), vertebral body height (BH), local kyphosis (LK), inter-spinous distance (ISD) and inter-pedicular distance (IPD) will be measured in CT scans and radiographs (if available). PLC injury will be determinated with the gold standard method (MRI).

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-10-01
• Completion: 2018-06-01
• First posted: 2016-11-01
• Last updated: 2020-08-13

Locations

5 sites across 5 countries: China, Egypt, India, South Korea, United Kingdom