Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-06-30

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)

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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.

Conditions

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Spinal Deformity Spinal Fractures Spinal Injuries Kyphosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Retrospective radiological evaluation

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No