Accuracy And Safety of Trans Pedicular Screw Fixation of The Sub-axial Cervical Spine Using A Triad- Dependent Technique

May 4, 2023 updated by: Mahmoud Abdelrahman Saleh El Attar, Assiut University

The Accuracy And Safety of Trans Pedicular Screw Fixation of The Sub-axial Cervical Spine Using A Triad- Dependent Technique (TDT)

The use of the pedicle screw system has become increasingly popular for treating an unstable cervical spine resulting from traumatic, degenerative, inflammatory, and neoplastic conditions. Because the cervical pedicle screw (CPS) has superior bio mechanical stability as the lateral mass screw or trans articular screw , pedicle screws allow for shorter instrumentation with improved spinal alignment. However, CPS insertion is technically demanding because of the anatomical variations in cervical pedicle size, lack of anatomical landmarks, small pedicle diameter, and the large transverse angle of cervical pedicles . The potential risk of injury to neurovascular structures, such as the vertebral artery, spinal cord, or nerve roots, caused by CPS remains a great concern. Therefore, accurate and safe CPS insertion techniques are necessary.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The use of the pedicle screw system has become increasingly popular for treating an unstable cervical spine resulting from traumatic, degenerative, inflammatory, and neoplastic conditions. Because the cervical pedicle screw (CPS) has superior bio mechanical stability as the lateral mass screw or trans articular screw , pedicle screws allow for shorter instrumentation with improved spinal alignment. However, CPS insertion is technically demanding because of the anatomical variations in cervical pedicle size, lack of anatomical landmarks, small pedicle diameter, and the large transverse angle of cervical pedicles . The potential risk of injury to neurovascular structures, such as the vertebral artery, spinal cord, or nerve roots, caused by CPS remains a great concern. Therefore, accurate and safe CPS insertion techniques are necessary.

Although a number of studies have evaluated the morphometric of cervical pedicles to support accurate placement of pedicle screws , the results are inconclusive. Therefore, several techniques using lateral fluoroscopy , pedicle axis view by oblique fluoroscopy , laminoframinotomy and computer-assisted navigation systems for CPS insertion have been advocated. Determining an appropriate entry point for screw insertion as well as a proper trajectory angle of the screw on the axial plane is important for successful pedicle screw placement. Here, we present our method using a fashioned triad- dependent technique (TDT) which is a combination of three methods 1-preoperative planning of the selected pedicle using 3-diamentional multi-slice CT to measure pedicle transverse angle (PTA) , pedicle outer diameter(POD)and pedicle trajectory -contralateral lamina angle 2-AP and oblique fluoroscopy to determine pedicle entry point (PEP), parallelism to vertebral end plate and 4 direction cortical violation (medial, lateral, superior, inferior) 3-interlaminar confirmatory key hole for tactile cue of medial ,superior, and inferior borders of the pedicle and related nerve root to evaluate the accuracy and safety of pedicle screw placement in patients with sub axial cervical spine disorders treated using our method.

Study Type

Observational

Enrollment (Anticipated)

20

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

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

All patients presented with degenerative or traumatic cervical spine matched the inclusion criteria will enrolled in our study from April 2023 to April 2024

Description

Inclusion Criteria:

  1. traumatic sub axial cervical spine injuries.
  2. degenerative cervical spine disorders necessitating cervical fusion

Exclusion Criteria:

  1. congenital anomaly of the cervical spine
  2. scoliotic deformity of the cervical spine
  3. sever osteoporosis
  4. congenital malformation of the pedicle.

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

Cohorts and Interventions

Group / Cohort
Patients
All patients presented with degenerative or traumatic cervical spine matched the inclusion criteria will enrolled in our study from April 2023 to April 2024.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological accuracy
Time Frame: Immediately post Operative

A. X-ray AP and lateral

B. MSCT: Placements of pedicle screws will be assessed using CT data and outcome-based classifications:

2 mm increment classification:

  • Type 0 (good): Screw within the pedicle medullary canal.
  • Type 1 (acceptable): Minimal penetration of the pedicle wall by the screw (<2 mm of medial or lateral cortical perforation or anterior cortex perforation).
  • Type 2 (unacceptable): Less than half of the diameter of the screw was outside the pedicle wall (2-4 mm of perforation).
  • Type 3 (grievous): More than half of the diameter of the screw was outside the pedicle wall (>4 mm of perforation) (spinal cord injury or screw abutting vertebral artery).
Immediately post Operative

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 (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ASTPSF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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