Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-01-02 @ 1:16 PM
Study NCT ID:
NCT07130461
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2025-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Surgical Implications of the Arcuate Foramen: A 3D CT-Based Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-31', 'size': 206458, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-11T08:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Arcuate Foramen Variants', 'timeFrame': 'Baseline (single review of existing imaging data)', 'description': 'Proportion of participants with complete arcuate foramen identified on 3D computed tomography (CT).\n\nUnit of Measure: Percentage (%) of participants.\n\nMeasurement Tool: High-resolution 3D reconstructed craniovertebral junction CT images, evaluated independently by two neuroradiologists.\n\nAnalysis: Proportion calculated with 95% confidence intervals (CI).'}], 'secondaryOutcomes': [{'measure': 'Association between Arcuate Foramen Type and Demographic Characteristics (Age and Sex)', 'timeFrame': 'Baseline.', 'description': "Description: Relationship between arcuate foramen type (complete vs. incomplete) and patient demographics, including age and sex distribution.\n\nUnit of Measure:\n\nAge: Mean ± standard deviation (years)\n\nSex: Percentage (%) of male and female participants\n\nMeasurement Tool: Demographic data (age and sex) recorded from electronic medical records.\n\nAnalysis:\n\nAge: Independent t-test or Mann-Whitney U test; effect size with 95% confidence interval (CI).\n\nSex: Chi-square test or Fisher's exact test; odds ratio (OR) with 95% CI.\n\nUnit of Measure: Mean ± standard deviation (years).\n\nMeasurement Tool: Age recorded from electronic medical records.\n\nAnalysis: Independent t-test or Mann-Whitney U test; effect size with 95% CI."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arcuate Foramen', '3D Computed Tomography', 'Vertebral Artery', 'Volume Rendering', 'OsiriX'], 'conditions': ['Arcuate Foramen', 'Anatomical Variations', 'Spine Surgery Complications']}, 'referencesModule': {'references': [{'pmid': '29486308', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '28621616', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24055572', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.\n\nThe 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.', 'detailedDescription': "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.\n\nThis 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.\n\nPrevalence 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years at the time of imaging\n* High-quality CT or CTA images including the atlas (C1) vertebra and posterior arch\n* Imaging obtained between January 2023 and July 2025 at Giresun University Faculty of Medicine\n* Images suitable for 3D volume rendering analysis without significant artifacts\n\nExclusion Criteria:\n\n* Motion or metallic artifact preventing adequate evaluation of atlas anatomy\n* Prior cervical spine surgery or trauma affecting the atlas\n* Congenital anomalies or severe deformity of the atlas obscuring posterior arch assessment\n* Incomplete demographic or imaging data'}, 'identificationModule': {'nctId': 'NCT07130461', 'briefTitle': 'Prevalence and Surgical Implications of the Arcuate Foramen: A 3D CT-Based Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Three-Dimensional Computed Tomography Assessment of Arcuate Foramen Variants and Their Surgical Implications: A Retrospective Observational Study', 'orgStudyIdInfo': {'id': 'E-53593568-771-250207806'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Adults Undergoing Head CT/CTA (2023-2025)', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '(506) 291 66 78', 'city': 'Giresun', 'country': 'Turkey (Türkiye)', 'facility': 'Giresun University Faculty of Medicine', 'geoPoint': {'lat': 40.91698, 'lon': 38.38741}}], 'overallOfficials': [{'name': 'Tamer Tamdogan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Giresun University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study involves retrospective analysis of de-identified radiological images. Individual participant data will not be shared to protect patient confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ilke Tamdogan', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}