Lumbosacral AnomaliesLSTVNCT06566846
Lumbosacral Transitional Vertebra Prevalence Among Egypt Population and Its Association With Lumbar Degeneration
An observational study of Lumbosacral Anomalies, run by Assiut University.
Trial summary
retrospective cross sectional study Study Setting: Cases will be recruited from the recorded data system at the department of diagnostic radiology, Assiut University. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbosacral Anomalies
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to Dec 2025
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will include all patients underwent KUB CT in Assuit university hospital at one year.
Who may be able to join
- • All MSCT KUB studies from 2022 till 2023
- age between 20-50
Who cannot join
- 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
About this study
Official title: Lumbosacral Transitional Vertebra(LSTV ) Prevalence in Egypt Population and Its Association With Lumbar Degeneration :Retrospective Evaluation of Consecutive Abdominal CT Scans
retrospective cross sectional study Study Setting: Cases will be recruited from the recorded data system at the department of diagnostic radiology, Assiut University.
Read the 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.
- Conditions
- Lumbosacral Anomalies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LSTV group and control group | Not described | |
| 1 and 2 | 1. for cases with LSTV 2. for normal studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence
prevalence of LSTV among egyptians
Measured: one year
Secondary outcomes (4)
correlation of LSTV with lumbar disc degeneration
association between LSTV and disc height ,segmental disc wedge angle and degree of disc prolapse(mild ,moderate ,severe)
Measured: one year
correlation of LSTV with facet joint arthropathy
fact joint arthropathy will be assessed as unilateral ,bilateral and its degree(mild ,moderate ,severe)
Measured: one year
correlation of LSTV with sacroiliac degeneration
sacroiliac joint will be assessed as unilateral ,bilateral and degree (mild ,moderate ,severe)
Measured: one year
correlation of LSTV with paravertebral muscle volume
bilateral psoas muscle volume in cubic centimeter
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 posted22 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral AnomaliesStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa Mostafa El-kossi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566846
- Sponsor's protocol ID
- AssuitU12345
- Acronym
- LSTV
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 22 Aug 2024
- 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbosacral Transitional Vertebra(LSTV ) Prevalence in Egypt Population and Its Association With Lumbar Degeneration :Retrospective Evaluation of Consecutive Abdominal CT Scans
- ClinicalTrials.gov ID
- NCT06566846
- Acronym / sponsor ID
- LSTV / AssuitU12345
- Conditions
- Lumbosacral Anomalies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Aug 2024 (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.
retrospective cross sectional study Study Setting: Cases will be recruited from the recorded data system at the department of diagnostic radiology, Assiut University.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSTV group and control group | – | – |
| 1 and 2 | – | –1. for cases with LSTV 2. for normal studies |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will include all patients underwent KUB CT in Assuit university hospital at one year.
Key inclusion criteria (2 listed)
- • All MSCT KUB studies from 2022 till 2023
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence
Time frame: one year
prevalence of LSTV among egyptians
4 secondary outcomes
correlation of LSTV with lumbar disc degeneration
Time frame: one year
correlation of LSTV with facet joint arthropathy
Time frame: one year
correlation of LSTV with sacroiliac degeneration
Time frame: one year
correlation of LSTV with paravertebral muscle volume
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbosacral Anomalies, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
prevalence (time frame: one year). 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 22 Aug 2024.