Analysis of Sub Axial Cervical Pedicle Spine Based on CT

September 15, 2024 updated by: Michael Atef Mikhaeel, Assiut University

Morphometric Analysis of Sub Axial Cervical Spine Pedicle in Egyptian Population

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Sample size was calculated using Epi- Info7. According to results of previous study (put ref.) , the pullout strength failed by fracture of pedicle screw in 40% of patients undergoing cervical spine CT. Based on this percentage, confidence limits of 7% and a confidence level of 80%, the sample needed for the study was estimated to be about 80 patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of feasibility of sub axial cervical spine pedicle
Time Frame: Baseline
Morphometric Analysis of sub axial cervical spine pedicle in Egyptian population
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2024

Primary Completion (Estimated)

May 21, 2025

Study Completion (Estimated)

June 12, 2026

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Cervical pedicle screw

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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