Analysis of Sub Axial Cervical Pedicle Spine Based on CT

NCT ID: NCT06445348

Last Updated: 2024-09-19

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

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-30

Study Completion Date

2026-06-12

Brief Summary

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The aim of study to analyze morphometry of sub axial cervical spine pedicle in an Egyptian population based on computed tomography (CT) and thus asses the safety and feasibility of cervical pedicle screw in the sub axial cervical spine

Detailed Description

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Cervical pedicle screw (CPS) fixation is found to be superior compared with lateral mass screws because it provides more axial, bending and torsional stability and has a low risk of loosening with cyclical loading . Despite biomechanical superiority, CPS fixation is not universally accepted among surgeon s because their accuracy and safety remain technically challenging because of the close proximity of vital structures as spinal cord and vertebral artery and inherent variability in pedicle at each level. In addition. limited space is available for screw placement because of complex of cervical spine vertebrae. Therefore, the risk of complication due to screw violation of the adjacent vascular and neural structures is expected to be high when performing the operation without a clear understanding of morphometric characteristics of the pedicle .Morphometry of the cervical pedicles was studied before using cadavers but comparative computed tomography (CT) data from the age matched population shown significant differences. Recent advances in CT have made anatomic measurements more accurate. The present study was undertaken to determine the 3-dimensional pedicle geometry by calculating variables like pedicle length (PL). Pedicle height (PH). Pedicle width (PW), Pedicle axis length (PAL), Pedicle transverse angulation (PTA), Pedicle sagittal angulation (PSA), Superior pedicle distance (SPD), and lateral pedicle distance (LPD). Fortunately, computed tomography (CT) scanning become a routine preoperative examination in spinal surgery patients.

Conditions

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Cervical Pedicle Screw

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cervical pedicle screw

cervical pedicle screw

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Individuals from 16 to 65 years old present to Assuit university hospital and undergo cervical spine CT scan for unrelated cause

Exclusion Criteria

* individuals with a history of cervical spine abnormalities.
* individuals with previous cervical spine injury
* individuals with congenital or developmental malformations of cervical spine patients with inflammatory. infectious, neoplastic condition
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Michael Atef Mikhaeel

physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Michael Mikhaeel, Resident

Role: CONTACT

01283635331

Mahmoud Fouad, professor

Role: CONTACT

01142227270

References

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Farooque K, Yadav R, Chowdhury B, Gamanagatti S, Kumar A, Meena PK. Computerized Tomography-Based Morphometric Analysis of Subaxial Cervical Spine Pedicle in Asymptomatic Indian Population. Int J Spine Surg. 2018 Aug 3;12(2):112-120. doi: 10.14444/5017. eCollection 2018 Apr.

Reference Type BACKGROUND
PMID: 30276069 (View on PubMed)

Other Identifiers

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Cervical pedicle screw

Identifier Type: -

Identifier Source: org_study_id

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