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Lumbosacral Transitional VertebraeNCT07256366

How Reliable Are Routine Radiological Imaging Methods in Diagnosing Lumbosacral Transitional Vertebrae and Identifying the Pathological Disc Level?

An observational study of Lumbosacral Transitional Vertebrae and Thoracolumbar Transitional Vertebra, run by Marmara University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this study is to evaluate how accurately transitional vertebrae can be identified using routinely employed clinical imaging methods, including thoracolumbar direct radiography and lumbar MRI with axial and sagittal sequences. Read more about this study

Who is it for?
Ages 18 to 75 years
How many people
250 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2025to 15 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study will include adult patients aged 18 to 75 years who present to the outpatient Algology clinic with complaints of low back and leg pain. Participants must receive a clinical diagnosis of lumbar radicular pain based on history, physical examination, and lumbar MRI findings. Only patients with complete and accessible medical records will be included. Individuals with a history of spinal surgery will be excluded from the study. Sample size of the study: 250

Who may be able to join

  • Age between 18 and 75 years
  • Presenting to the outpatient clinic with low back and leg pain
  • Diagnosis of lumbar radicular pain based on history, physical examination, and lumbar MRI findings
  • Willingness and ability to provide informed consent to participate in the study

Who cannot join

  • History of spinal surgery
  • Patients with incomplete or unavailable medical records within the hospital information system

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Serdar Kokar contact

srdrkkr@hotmail.com

Turkey (Türkiye)1 site
  • Marmara Üniversitesi Tıp Fakültesi

    Istanbul, Maltepe, 34854

    Secretary General Secretary, +90 2166254545, kasimogluoguzhan@gmail.com

Other trials in Turkey (Türkiye)

About this study

The aim of this study is to evaluate how accurately transitional vertebrae can be identified using routinely employed clinical imaging methods, including thoracolumbar direct radiography and lumbar MRI with axial and sagittal sequences. The study also seeks to determine how anatomical markers commonly used in the literature for vertebral level identification correspond to vertebral levels in the Turkish population, and whether a new potential relationship between these anatomical markers can be identified to improve accurate vertebral numbering. Additionally, the study will assess the relationship between thoracolumbar transitional vertebra (TLTV) and lumbosacral transitional vertebra (LSTV) variations, and ultimately aims to provide new data to determine which imaging-based approach offers the highest diagnostic accuracy.

Read the detailed description

Lumbosacral transitional vertebrae (LSTV) include morphological variants in which L5 is partially or completely fused with the sacrum (sacralization), or in which S1 assumes additional lumbar characteristics (lumbarization). The most commonly used classification is the Castellvi system, which categorizes these variations from Type I to Type IV. Based on data from the past decade, the prevalence of LSTV ranges between 7% and 36%. LSTV may restrict motion at the transitional segment and consequently lead to disc degeneration in adjacent levels. One study reported that the Pfirrmann grade of the disc above the transitional vertebra was significantly higher in individuals with LSTV. The most reliable method for diagnosing LSTV is counting vertebrae caudally from the C2 vertebra on whole-spine imaging. Since the presence of LSTV can result in incorrect vertebral level identification during surgical or interventional procedures, recognizing these variations is essential.

Transitional segments located in the thoracolumbar junction that display both thoracic and lumbar characteristics are defined as thoracolumbar transitional vertebrae (TLTV). TLTV commonly involves atypical rib formation at the last thoracic or first lumbar vertebrae. The presence of a 13th rib-also termed a lumbar rib-is another variant that complicates vertebral level identification. In radiography, the last vertebra with a true rib is generally accepted as T12, and lumbar vertebrae are counted accordingly. However, in some individuals, the transverse process of the first lumbar vertebra develops a rib-like morphology. This structure is referred to as a lumbar rib and may create ambiguity during lumbar level identification on radiographs. Although numerous studies have examined the prevalence and clinical implications of LSTV, data on TLTV remain insufficient.

Various imaging modalities and anatomical markers have been used for detecting transitional vertebrae. The most reliable method for identifying both LSTV and TLTV is whole-spine MRI or CT imaging that allows vertebral counting from C2 caudally. This approach directly reveals segmental anomalies and numbering variations. Although anatomical markers such as the aortic bifurcation, inferior vena cava bifurcation, right renal artery, and conus medullaris have been proposed for determining lumbar vertebral levels, their anatomical variability limits their reliability, particularly when used in isolation. Moreover, studies have shown that the position of these markers shifts depending on the presence of transitional vertebrae: markers tend to be positioned more caudally in sacralized vertebrae and more cranially in lumbarized vertebrae.

In this cross-sectional study, patients presenting with low back and leg pain to the Algology Division of the Department of Physical Medicine and Rehabilitation at Marmara University, who are diagnosed with lumbar radicular pain based on clinical evaluation and MRI, will be assessed. Demographic data, including age, sex, height, weight, and body mass index, will be recorded.

In the first stage of evaluation, the level of the disc herniation responsible for lumbar radicular pain will be determined on routine lumbar MRI sequences using anatomical markers described in the literature (right renal artery, conus medullaris, aortic and inferior vena cava bifurcations). Thoracolumbar and lumbosacral two-view radiographs will also be evaluated to identify transitional vertebrae and to note the presence of lumbar ribs, rudimentary thoracic ribs, or other costal anomalies. For each anatomical marker, the disc level suggested by that marker will be recorded separately, and the level indicated by the majority of markers will also be noted. If a transitional vertebra is identified on radiographs, the disc level determined on MRI will be revised accordingly.

In the second stage, an independent, blinded investigator will determine the presence of TLTV and LSTV, as well as the pathological disc level, using a sagittal whole-spine MRI localizer that includes the entire spinal axis from C2 to the sacrum. In the final analysis, the agreement between the two assessment methods will be examined. The study will determine the accuracy of level identification based on axial and sagittal lumbar MRI sequences and thoracolumbar/lumbosacral radiographs. Additionally, the detectability of lumbar ribs or rib agenesis based solely on radiographic findings will be evaluated. Finally, the true anatomical level corresponding to each marker will be identified using the whole-spine localizer and reported accordingly.

Keywords
LSTV, TLTV, lomber rib, spinal imaging accuracy, transitional vertebrae, vertebral level misidentification
Medical subject headings
Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07256366
Study groupRoleWhat they receive
GROUP 1: Patients who applied to the outpatient clinic with complaints of back and leg painNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of Vertebral Level Identification Using Routine Lumbar MRI

    Accuracy of vertebral level identification based solely on routine lumbar MRI sequences (axial and sagittal), compared with whole-spine sagittal localizer imaging (gold standard). Accuracy will be calculated as the proportion of correctly identified pathological disc levels.

    How It Will Be Measured:

    Correct level matching (Yes/No) Accuracy (%) = (Correct identifications / Total cases) × 100

    Measured: At the time of imaging evaluation (baseline)

Secondary outcomes (3)
  1. Agreement Between MRI-Based Anatomical Landmarks and True Vertebral Levels

    Agreement between each anatomical marker (aortic bifurcation, inferior vena cava bifurcation, right renal artery, conus medullaris) and the true vertebral level determined by whole-spine localizer imaging.

    Measurement: Cohen's kappa (κ), absolute level difference (levels above/below), mean ± SD

    Measured: Baseline

  2. Frequency and Types of Transitional Vertebrae (LSTV and TLTV)

    Prevalence and subtype distribution of lumbosacral transitional vertebrae (Castellvi classification) and thoracolumbar transitional vertebrae. Measurement: n (%) by subtype.

    Measured: Baseline

  3. Effect of Transitional Vertebrae on Level Misidentification

    Comparison of the misidentification rate of disc levels in patients with vs. without transitional vertebrae.

    Measurement: Misidentification rate (%), Relative risk, 95% CI

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2025
  2. Study start15 Dec 2025 (estimated)
  3. Primary completion15 Mar 2026 (estimated)
  4. Study completion15 Jun 2026 (estimated)

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07256366
Sponsor's protocol ID
MarmaraU-FTR-OK-2
Status last verified
Nov 2025
First submitted
20 Nov 2025
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbosacral Transitional Vertebrae and Thoracolumbar Transitional Vertebra, run by Marmara University at 1 site in Turkey (Türkiye).

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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 1 Dec 2025. 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 Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oguzhan Kasimoglu (+90 5448911835, kasimogluoguzhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of Vertebral Level Identification Using Routine Lumbar MRI (time frame: At the time of imaging evaluation (baseline)). 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 1 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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