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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMarmara University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of spinal surgery

Patients with incomplete or unavailable medical records within the hospital information system

Trial 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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 1 trial group
Group A: GROUP 1: Patients who applied to the outpatient clinic with complaints of back and leg pain

Trial outcomes

Primary outcomes

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

Time frame
At the time of imaging evaluation (baseline)

Secondary outcomes

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

Time frame
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.

Time frame
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

Time frame
Baseline

Other outcomes

Sponsors and contacts

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