SPINAL FractureNCT03269851
Parameters of Neurological Deficit After Thoracolumbar Fractures
An observational study of SPINAL Fracture, run by Assiut University at 1 site in Egypt.
Trial summary
To detect Radiological parameters affecting neurological injury after thoracolumbar spinal fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SPINAL Fracture
- What is being tested?
- computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 21 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiological Parameters Predicting Neurological Injury After Thoracolumbar Spinal Fractures
To detect Radiological parameters affecting neurological injury after thoracolumbar spinal fractures.
Read the 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.
- Conditions
- SPINAL Fracture
- Being tested
- computed tomography
- Keywords
- neurological deficit
- Medical subject headings
- Spinal Fractures, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyRadiation
ct will be done to detect radiological risk factors for neurological deficits after thoracolumbar fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure spinal canal stenosis by cubic cm
CT-Radiological parameters measured in patients with or without thoracolumbar fractures .
Measured: one year
To measure sagittal alignment of vertebral column by cobb angle
CT-Radiological parameters measured in patients with or without thoracolumbar fractures
Measured: one year
To measure vertebral body compression by cm
CT-Radiological parameters measured in patients with or without thoracolumbar fractures
Measured: one year
To measure type of fracture according to AO classification
CT-Radiological parameters measured in patients with or without thoracolumbar fractures
Measured: one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Nov 2018
- Primary completion31 Oct 2019
- Study completion21 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SPINAL FractureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zamboo Safwat, Assiut University
- Investigators
- Mohammed G. Hassan, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269851
- Sponsor's protocol ID
- Neurological deficit
- Other IDs
- Thoracolumbar fractures
- Status last verified
- Jul 2021
- First submitted
- 29 Aug 2017
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Parameters Predicting Neurological Injury After Thoracolumbar Spinal Fractures
- ClinicalTrials.gov ID
- NCT03269851
- Acronym / sponsor ID
- Neurological deficit
- Conditions
- SPINAL Fracture
- Keywords
- neurological deficit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 21 Mar 2020 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomographyct will be done to detect radiological risk factors for neurological deficits after thoracolumbar fractures | Radiation | – |
Primary outcome
To Measure spinal canal stenosis by cubic cm
Time frame: one year
CT-Radiological parameters measured in patients with or without thoracolumbar fractures .
To measure sagittal alignment of vertebral column by cobb angle
Time frame: one year
CT-Radiological parameters measured in patients with or without thoracolumbar fractures
To measure vertebral body compression by cm
Time frame: one year
CT-Radiological parameters measured in patients with or without thoracolumbar fractures
To measure type of fracture according to AO classification
Time frame: one year
CT-Radiological parameters measured in patients with or without thoracolumbar fractures
1 secondary outcome
Proportion of Neurological deficit among patients with thoracolumbar spine fractures.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- The significance of thoracolumbar spinal canal size in spinal cord injury patients.Link provided by the sponsor.
- CT scan prediction of neurological deficit in thoracolumbar burst fractures.Link provided by the sponsor.
- Relationship between traumatic spinal canal stenosis and neurologic deficits in thoracolumbar burst fractures.Link provided by the sponsor.
- Neurologic injury and recovery in patients with burst fracture of the thoracolumbar spine.Link provided by the sponsor.
- Correlation among canal compromise, neurologic deficit, and injury severity in thoracolumbar burst fractures.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed G. Hassan study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SPINAL Fracture, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Measure spinal canal stenosis by cubic cm (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.