Skip to main content
OpenTrials
Completed

NCT Number: NCT07130461

Prevalence and Surgical Implications of the Arcuate Foramen: A 3D CT-Based Observational Study

This study aims to determine the prevalence and types of the arcuate foramen (AF), an anatomical variation of the first cervical vertebra (atlas), using three-dimensional computed tomography (3D CT). The arcuate foramen is formed when a bony bridge develops over the groove for the vertebral artery. Although often asymptomatic, it may increase the risk of vascular or nerve injury during surgery in the craniovertebral junction region.

In this retrospective observational study, 3D CT scans of 200 adult patients obtained between January 2023 and July 2025 at Giresun University Faculty of Medicine were reviewed. The presence of AF was classified as complete or incomplete, and also categorized according to its location (right, left, or bilateral). Associations with demographic variables (age, sex) were analyzed.

The results will help improve awareness of AF in preoperative planning for neurosurgical and spinal procedures, potentially reducing the risk of complications involving the vertebral artery and surrounding neurovascular structures.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Giresun University Faculty of Medicine

Giresun, (506) 291 66 78, Turkey (Türkiye)

About this study

The arcuate foramen (AF) is an anatomical variation of the atlas (C1 vertebra) that occurs when a bony bridge forms over the groove for the vertebral artery, creating a complete or partial tunnel. While frequently asymptomatic, its presence has been associated with conditions such as vertebrobasilar insufficiency, cervicogenic headache, and chronic neck pain. Importantly, AF may alter the course of the vertebral artery and suboccipital nerve, increasing the risk of injury during craniovertebral junction surgery, C1-C2 instrumentation, and posterior fossa approaches.

This retrospective cross-sectional study reviewed 3D computed tomography (CT) images of 200 adult patients obtained between January 2023 and July 2025 at Giresun University Faculty of Medicine. Images were reconstructed and analyzed using OsiriX MD software with a 3D volume rendering technique. AF was classified as complete or incomplete and further categorized by side (right, left, or bilateral). Associations with demographic variables, including age and sex, were examined.

Prevalence estimates were calculated with 95% confidence intervals. Interobserver agreement between two experienced neurosurgeons was assessed using Cohen's Kappa statistic. The findings aim to provide a clearer understanding of AF prevalence in the Turkish population and its potential surgical relevance. By identifying these variations preoperatively, surgeons can better plan instrumentation trajectories and minimize neurovascular complications in craniovertebral and upper cervical procedures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years at the time of imaging
  • High-quality CT or CTA images including the atlas (C1) vertebra and posterior arch
  • Imaging obtained between January 2023 and July 2025 at Giresun University Faculty of Medicine
  • Images suitable for 3D volume rendering analysis without significant artifacts

Exclusion criteria

  • Motion or metallic artifact preventing adequate evaluation of atlas anatomy
  • Prior cervical spine surgery or trauma affecting the atlas
  • Congenital anomalies or severe deformity of the atlas obscuring posterior arch assessment
  • Incomplete demographic or imaging data

Treatment and study plan

Primary outcomes

  1. Prevalence of Arcuate Foramen Variants

    Time frame: Baseline (single review of existing imaging data)

    Proportion of participants with complete arcuate foramen identified on 3D computed tomography (CT).

    Unit of Measure: Percentage (%) of participants.

    Measurement Tool: High-resolution 3D reconstructed craniovertebral junction CT images, evaluated independently by two neuroradiologists.

    Analysis: Proportion calculated with 95% confidence intervals (CI).

Secondary outcomes

  1. Association between Arcuate Foramen Type and Demographic Characteristics (Age and Sex)

    Time frame: Baseline.

    Description: Relationship between arcuate foramen type (complete vs. incomplete) and patient demographics, including age and sex distribution.

    Unit of Measure:

    Age: Mean ± standard deviation (years)

    Sex: Percentage (%) of male and female participants

    Measurement Tool: Demographic data (age and sex) recorded from electronic medical records.

    Analysis:

    Age: Independent t-test or Mann-Whitney U test; effect size with 95% confidence interval (CI).

    Sex: Chi-square test or Fisher's exact test; odds ratio (OR) with 95% CI.

    Unit of Measure: Mean ± standard deviation (years).

    Measurement Tool: Age recorded from electronic medical records.

    Analysis: Independent t-test or Mann-Whitney U test; effect size with 95% CI.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Three-Dimensional Computed Tomography Assessment of Arcuate Foramen Variants and Their Surgical Implications: A Retrospective Observational Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.