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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

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Study Contact

Study Contact

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Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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