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

NCT ID: NCT07130461

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arcuate Foramen Anatomical Variations Spine Surgery Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All Adults Undergoing Head CT/CTA (2023-2025)

Consecutive adult patients (≥18 years) whose high-quality 3D CT or CTA images included the atlas (C1) vertebra. Images were evaluated retrospectively for the presence, type (complete/incomplete), and laterality (right/left/bilateral) of the arcuate foramen.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Ilke Tamdogan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tamer Tamdogan, MD

Role: PRINCIPAL_INVESTIGATOR

Giresun University Faculty of Medicine

Locations

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Giresun University Faculty of Medicine

Giresun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Arslan D, Ozer MA, Govsa F, Kitis O. The Ponticulus Posticus as Risk Factor for Screw Insertion into the First Cervical Lateral Mass. World Neurosurg. 2018 May;113:e579-e585. doi: 10.1016/j.wneu.2018.02.100. Epub 2018 Feb 25.

Reference Type RESULT
PMID: 29486308 (View on PubMed)

Pekala PA, Henry BM, Pekala JR, Hsieh WC, Vikse J, Sanna B, Walocha JA, Tubbs RS, Tomaszewski KA. Prevalence of foramen arcuale and its clinical significance: a meta-analysis of 55,985 subjects. J Neurosurg Spine. 2017 Sep;27(3):276-290. doi: 10.3171/2017.1.SPINE161092. Epub 2017 Jun 16.

Reference Type RESULT
PMID: 28621616 (View on PubMed)

Elliott RE, Tanweer O. The prevalence of the ponticulus posticus (arcuate foramen) and its importance in the Goel-Harms procedure: meta-analysis and review of the literature. World Neurosurg. 2014 Jul-Aug;82(1-2):e335-43. doi: 10.1016/j.wneu.2013.09.014. Epub 2013 Sep 18.

Reference Type RESULT
PMID: 24055572 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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E-53593568-771-250207806

Identifier Type: -

Identifier Source: org_study_id

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