跳至主要内容
临床试验/NCT07256366
NCT07256366尚未招募不适用

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

Marmara University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Accuracy of Vertebral Level Identification Using Routine Lumbar MRI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Accuracy of Vertebral Level Identification Using Routine Lumbar MRI

时间窗: At the time of imaging evaluation (baseline)

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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