Parameters of Neurological Deficit After Thoracolumbar Fractures

Radiological Parameters Predicting Neurological Injury After Thoracolumbar Spinal Fractures

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

Study Overview

• Status: Completed
• Conditions: SPINAL Fracture
• Intervention / Treatment: Radiation: computed tomography

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Measure spinal canal stenosis by cubic cm	CT-Radiological parameters measured in patients with or without thoracolumbar fractures .	one year
To measure sagittal alignment of vertebral column by cobb angle	CT-Radiological parameters measured in patients with or without thoracolumbar fractures	one year
To measure vertebral body compression by cm	CT-Radiological parameters measured in patients with or without thoracolumbar fractures	one year
To measure type of fracture according to AO classification	CT-Radiological parameters measured in patients with or without thoracolumbar fractures	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Neurological deficit among patients with thoracolumbar spine fractures.	Number of patients with neurological deficit to the total number of patients with thoracolumbar spine fractures.	one year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Mohammed G. Hassan, Assiut University

Publications and helpful links

Helpful Links

• The significance of thoracolumbar spinal canal size in spinal cord injury patients.
• Relationship between traumatic spinal canal stenosis and neurologic deficits in thoracolumbar burst fractures.
• Neurologic injury and recovery in patients with burst fracture of the thoracolumbar spine.
• Correlation among canal compromise, neurologic deficit, and injury severity in thoracolumbar burst fractures.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ACTUAL): October 31, 2019
• Study Completion (ACTUAL): March 21, 2020

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (ACTUAL): September 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: neurological deficit
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures
• Other Study ID Numbers: Neurological deficit; Thoracolumbar fractures (OTHER: Assiut University Hospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No