NCT07130461

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

August 11, 2025

Last Update Submit

August 15, 2025

Conditions

Keywords

Arcuate Foramen3D Computed TomographyVertebral ArteryVolume RenderingOsiriX

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Arcuate Foramen Variants

    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).

    Baseline (single review of existing imaging data)

Secondary Outcomes (1)

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

    Baseline.

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (≥18 years) who underwent head computed tomography (CT) or computed tomography angiography (CTA) at Giresun University Faculty of Medicine between January 2023 and July 2025, whose images included the atlas (C1) vertebra and met quality criteria for three-dimensional reconstruction.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun University Faculty of Medicine

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

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • Tamer Tamdogan, MD

    Giresun University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 19, 2025

Study Start

July 1, 2025

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

This study involves retrospective analysis of de-identified radiological images. Individual participant data will not be shared to protect patient confidentiality.

Locations