Clinical trial NCT02950532: Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures
Official title: Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures (T11-L2): A Diagnostic Test Study to Analyze Sensitivity and Specificity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Deformity
Spinal Fractures
Spinal Injuries
Kyphosis
Keywords: Posterior ligamentous complex
Thoracolumbar fractures
Interspinous distance
Local kyphosis
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Local kyphosis (LK) and/or Inter-spinous distanceI (SD)
timeFrame: 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 outcomes:
measure: Sensitivity and specificity of superior-inferior end plate angle (SIEA)
timeFrame: 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).
measure: Sensitivity and specificity of vertebral body height (BH)
timeFrame: 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).
measure: Sensitivity and specificity of inter-pedicular distance (IPD)
timeFrame: 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 outcomes:
measure: Accuracy of CT scan measurements
timeFrame: 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).
measure: Inter-rater reliability
timeFrame: 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).
Locations:
city: Hangzhou
country: China
facility: The 1st Affiliated Hospital of Zhejiang University
city: Assiut
country: Egypt
facility: Assiut Universtiy Hospitals
city: Coimbatore
country: India
facility: Ganga Hospital
city: Uijeongbu-si
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
Study officials:
affiliation: Ganga Hospital
name: Shanmuganathan Rajasekaran, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: TESTING
name: Test Testing, MD
role: STUDY_CHAIR
References: