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Not yet recruiting NCT06445348

Analysis of Sub Axial Cervical Pedicle Spine Based on CT

Observational Cervical Pedicle Screw

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cervical pedicle screw.
Who it may be relevant to
Registry conditions: Cervical Pedicle Screw. Basic parameters: 16 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Morphometric Analysis of Sub Axial Cervical Spine Pedicle in Egyptian Population

Overview

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

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.

Interventions

  • Device Cervical pedicle screw
    cervical pedicle screw

Primary outcome measures

  • Assessment of feasibility of sub axial cervical spine pedicle [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 30276069

Identifiers

NCT: NCT06445348 · Cervical pedicle screw

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗