- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06566846
Lumbosacral Transitional Vertebra Prevalence Among Egypt Population and Its Association With Lumbar Degeneration (LSTV)
Lumbosacral Transitional Vertebra(LSTV ) Prevalence in Egypt Population and Its Association With Lumbar Degeneration :Retrospective Evaluation of Consecutive Abdominal CT Scans
Study Overview
Status
Conditions
Detailed Description
Study subjects:
Inclusion criteria:
- All patients underwent MSCT KUB from 2022 till 2023
- Age between 20-50 years old
Exclusion criteria:
- All cases below 20 and above 50 .
- previous history of lumbar spine surgery;
- non-degenerative pathologies in the lumbar spine which could interrupt the evaluation of lumbar spine degeneration, including spinal tumors, infections, and traumatic fractures;
- images with poor quality
Sample Size Calculation:
The study will include all patients underwent KUB CT in Assuit university hospital.
Objective of this research study will be accomplished through the following consecutive steps:
- Patient Enrolment and sample collection:
Sample are patients underwent MSCT KUB at our hospital , ASSUIT university at one year. Lumbosacral spine will be assessed for LSTV ,the patient images will be divided into two groups ,one which has LSTV as cases and other group with normal spine as control. both groups will be assessed for associated disc degeneration ,facet arthropathy sacroiliac joint degeneration ,paravertebral muscle volume and will be compared with control.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
• All MSCT KUB studies from 2022 till 2023
- age between 20-50
Exclusion Criteria:
- All cases below 20 and above 50 .
- previous history of lumbar spine surgery;
- non-degenerative pathologies in the lumbar spine which could interrupt the evaluation of lumbar spine degeneration, including spinal tumors, infections, and traumatic fractures;
- images with poor quality
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
LSTV group and control group
|
|
1 and 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevalence
Time Frame: one year
|
prevalence of LSTV among egyptians
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
correlation of LSTV with lumbar disc degeneration
Time Frame: one year
|
association between LSTV and disc height ,segmental disc wedge angle and degree of disc prolapse(mild ,moderate ,severe)
|
one year
|
|
correlation of LSTV with facet joint arthropathy
Time Frame: one year
|
fact joint arthropathy will be assessed as unilateral ,bilateral and its degree(mild ,moderate ,severe)
|
one year
|
|
correlation of LSTV with sacroiliac degeneration
Time Frame: one year
|
sacroiliac joint will be assessed as unilateral ,bilateral and degree (mild ,moderate ,severe)
|
one year
|
|
correlation of LSTV with paravertebral muscle volume
Time Frame: one year
|
bilateral psoas muscle volume in cubic centimeter
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AssuitU12345
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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