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

AO Clinical Investigation and Publishing Documentation

Status: Completed

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

Treatments: Other: Retrospective radiological evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT02950532

AOCID_PAM

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Cases

Description:

Retrospective radiological evaluation in cases presenting A3 or A4 TL burst fractures (AOSpine classification) between T11 to L2 with or without suspected PLC injury

Treatment:

Other: Retrospective radiological evaluation