Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures (PAM)

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)

Study Overview

• Status: Completed
• Conditions: Spinal Fractures; Spinal Injuries; Spinal Deformity; Kyphosis
• Intervention / Treatment: Other: Retrospective radiological evaluation

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Hangzhou, China, 310003
    • The 1st Affiliated Hospital of Zhejiang University
• Egypt
  • Assiut, Egypt, 71526
    • Assiut Universtiy Hospitals
• India
  • Coimbatore, India, 641 011
    • Ganga Hospital
• Korea, Republic of
  • Uijeongbu-si, Korea, Republic of, 118765
    • Uijeongbu St. Mary's Hospital
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participating study sites will retrospectively identify all eligible patients in the medical charts (i.e. who meet all of the inclusion and none of the exclusion criteria). If required by local regulations, patients choosing to participate will sign and date an informed consent form (ICF).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cases; 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; 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).

What is the study measuring?

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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Shanmuganathan Rajasekaran, Prof. MD, Ganga Hospital; Study Chair: Test Testing, MD, TESTING

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Posterior ligamentous complex; Thoracolumbar fractures; Interspinous distance; Local kyphosis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Back Injuries; Fractures, Bone; Spinal Fractures; Spinal Injuries; Kyphosis
• Other Study ID Numbers: AOCID_PAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No