Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures

Spinal Deformity Clinical Trial

— PAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950532
• Other study ID #: AOCID_PAM
• Status: Completed
• Start date: October 2016
• Est. completion date: June 2018

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Kyphosis
• Spinal Deformity
• Spinal Fractures
• Spinal Injuries

Intervention

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).

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital of Zhejiang University	Hangzhou
Egypt	Assiut Universtiy Hospitals	Assiut
India	Ganga Hospital	Coimbatore
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu-si
United Kingdom	Royal Victoria Hospital	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

China,  Egypt,  India,  Korea, Republic of,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accuracy of CT scan measurements	Accuracy describes how closely the measured value is to the true value and is an indicator of systematic errors. The accuracy of measurements of each CT scan parameter will be compared between the participating sites.	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).
Other	Inter-rater reliability	The inter-rater reliability is defined as the percent agreement between the measurements of the different parameters by the different observers. The CT scans and radiographs (if available) distributed to the participating sites will be measured at each site by all participating MDs within each team or at least by one trained PI.	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).
Primary	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	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).
Secondary	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).
Secondary	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).