Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures

Completed

• Conditions: Spinal Deformity; Kyphosis; Spinal Fractures; Spinal Injuries

• Registration Number: NCT02950532
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief 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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Primary Completion: 2017-10
• Study Completion: 2018-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of Local kyphosis (LK) and/or Inter-spinous distanceI (SD)	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 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.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of vertebral body height (BH)	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).	Is defined as the proportion of patients with PLC injury correctly diagnosed by an decrease in BH compared to MRI.
Sensitivity and specificity of inter-pedicular distance (IPD)	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).	Is defined as the proportion of patients with PLC injury correctly diagnosed by a increase in IPD compared to MRI.
Sensitivity and specificity of superior-inferior end plate angle (SIEA)	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).	Is defined as the proportion of patients with PLC injury correctly diagnosed by a increase in SIEA compared to MRI.

Trial Locations

Locations (5)

The 1st Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, China

Assiut Universtiy Hospitals; 🇪🇬 Assiut, Egypt

Ganga Hospital; 🇮🇳 Coimbatore, India

Uijeongbu St. Mary's Hospital; 🇰🇷 Uijeongbu-si, Korea, Republic of

Royal Victoria Hospital; 🇬🇧 Belfast, United Kingdom