Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Spinal Deformity, Spinal Fractures, Spinal Injuries, Kyphosis

Intervention / Treatment
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* Other: Retrospective radiological evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 60 years A3/A4 TL fracture between T11-L2 with or without PLC injury Pre-treatment CT scan and MRI. Radiographs (if available) Signed Informed consent, if required by EC/IRB Exclusion Criteria: Pathological fractures Multilevel contiguous and non-contiguous injuries Fractures with obvious spinous process split indicating tension band failure such as AO type B1 injuries Fractures with translation injuries or dislocations such as AO type C injuries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Retrospective radiological evaluation in cases presenting A3 or A4 TL burst fractures (AOSpine classification) between T11 to L2 with or without suspected PLC injury | Other: Retrospective radiological evaluation<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Local kyphosis (LK) and/or Inter-spinous distanceI (SD) | Sensitivity of LK and/or ISD Is defined as the proportion of patients with PLC injury correctly diagnosed by an increase in LK and/or ISD difference compared to MRI. The Specificity si defined as the proportion of patients with PLC injury correctly diagnosed by an increase in LK and/or ISD difference compared to MRI. The gold standard is a diagnostic test and it is the best accepted test that is assumed to be able to determine the true disease state. It is considered as the reference method or the best test available. | CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of superior-inferior end plate angle (SIEA) | Is defined as the proportion of patients with PLC injury correctly diagnosed by a increase in SIEA compared to MRI. | CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event). | 
| Sensitivity and specificity of vertebral body height (BH) | Is defined as the proportion of patients with PLC injury correctly diagnosed by an decrease in BH compared to MRI. | CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event). | 
| Sensitivity and specificity of inter-pedicular distance (IPD) | Is defined as the proportion of patients with PLC injury correctly diagnosed by a increase in IPD compared to MRI. | CT scans, MRI and x-rays were taken on admission into hospital after the patient got a thoracolumbar fracture. These images will be retrospectively analyzed (eligible images are from the date of the fracture up to 3 days after the event). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posterior ligamentous complex, Thoracolumbar fractures, Interspinous distance, Local kyphosis