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

NCT07256366 | Not Yet Recruiting

• 1 other identifier: MarmaraU-FTR-OK-2
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lumbosacral Transitional Vertebrae; Thoracolumbar Transitional Vertebra; Vertebral Level Misidentification; Lumbar Radiculopathy; Spinal Imaging Accuracy

Keywords

LSTV; TLTV; lomber rib; spinal imaging accuracy; transitional vertebrae; vertebral level misidentification

Outcome Measures

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

  At the time of imaging evaluation (baseline)

Secondary Outcomes (3)

• Agreement Between MRI-Based Anatomical Landmarks and True Vertebral Levels

  Baseline

• Frequency and Types of Transitional Vertebrae (LSTV and TLTV)

  Baseline

• Effect of Transitional Vertebrae on Level Misidentification

  Baseline

Study Arms (1)

GROUP 1: Patients who applied to the outpatient clinic with complaints of back and leg pain

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara Üniversitesi Tıp Fakültesi

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Oguzhan Kasimoglu

CONTACT

+90 5448911835; kasimogluoguzhan@gmail.com

Serdar Kokar

CONTACT

srdrkkr@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: December 15, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)