Clinical trial NCT03269851: Parameters of Neurological Deficit After Thoracolumbar Fractures
Official title: Radiological Parameters Predicting Neurological Injury After Thoracolumbar Spinal Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SPINAL Fracture
Keywords: neurological deficit
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with Acute (within one month) thoracolumbar spine fracture above 18 years old with or without neurological deficit in orthopaedics and trauma department of Assiut university hospital from 1st of November 2018 to 31 st of October 2019.

Brief summary: To detect Radiological parameters affecting neurological injury after thoracolumbar spinal fractures.

Detailed description: Thoracolumbar spine fractures are the most common spinal column fractures. High activity and lack of stability make it more prone to fractures.

Many studies have attempted to determine whether the neurological deficit in such fractures is related to spinal canal stenosis or other parameters observed on axial computed tomography (CT). However, this relationship remains controversial.

Few reports shed light on the relation between different imaging parameters like sagittal alignment, vertebral body compression, canal stenosis, and type of fracture according to AO classification with the severity of nerve damage.

These four radiographic parameters will be tested as expected risk factors for the neurological deficit in thoracolumbar fractures.

Eligibility criteria: Inclusion Criteria:

1. Any patient with Acute (within one month) thoracolumbar spine fracture above 18 years old with or without neurological deficit
2. In orthopaedics and trauma department of Assiut university hospital from 1st of November 2018 to 31 st of October 2019.

Exclusion Criteria:

* Patients younger than 18 years old.
* Patients suffering from preoperative neurological diseases that hinder our examination like peripheral neuropathy or previous strokes.
* Obtuned patients who cannot be properly examined like those with low GCS score.
* Patients with old thoracolumbar fractures more than one month duration.
* Patients with pathological spine fractures like those with osteoporosis and cancer metastasis.
* Patients with fracture type A0 according to AO classification.

Primary outcomes:
measure: To Measure spinal canal stenosis by cubic cm
timeFrame: one year
measure: To measure sagittal alignment of vertebral column by cobb angle
timeFrame: one year
measure: To measure vertebral body compression by cm
timeFrame: one year
measure: To measure type of fracture according to AO classification
timeFrame: one year
Secondary outcomes:
measure: Proportion of Neurological deficit among patients with thoracolumbar spine fractures.
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Mohammed G. Hassan
role: STUDY_CHAIR
References: