Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using O-arm Navigation VS Standard Cervical Distractor Screws

September 3, 2020 updated by: King Abdullah International Medical Research Center

A Comparison of Pedicle Screws Placement Accuracy in Thoracolumbar Spine Using Two Guidance Techniques: O-arm Navigation and Cervical Distractor Screws

Pedicle screw instrumentation is used nowadays mostly in spine fusion which is a surgical option for treating variety of conditions such as vertebral fractures, degenerative spine diseases, spine tumors and spine deformities. However, pedicle screws misplacement and breach may occur and be a great cause of morbidity. The breach rate can be as high as 20-39.8% but most of the time only small number is associated with complications. Surgeons use assistive technique to avoid screw breached and improve screw placement accuracy. Investigators aim in this study to compare accuracy of pedicle screws placement using two guidance techniques are O-arm navigation the latest assistive imaging technique that uses three-dimensional (3-D) real time images to allow the surgeons follow the screw's trajectory, and standard cervical distractor screws to mark the entry point and trajectory.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Saudi Arabia
    • Eastern Province
      • Jeddah, Eastern Province, Saudi Arabia, 21423
        • Recruiting
        • King Abdulaziz Medical City
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who need a thoracolumbar spine surgery that require pedicle screw insertion.

Exclusion Criteria:

  • Patients whose surgeries in cervical spine
  • Patients whose surgeries are for correction of deformities such as scoliosis and kyphosis, patients with infections or tumors.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neuronavigation / O-arm group
Under neural navigation with the use of intraoperative three dimensional imaging quality O-arm , pedicle screws inserted at the thoraolumbar/lumbar spine after insertion of the reference frame at the spinous process above or below the level of instrumentation followed by O-Arm imaging and uploading the images to the stelth navigation system and pedicle tract identification using instrumented tools guided by the Navigation polyaxial screws is inserted.
Procedure: Pedicle screws instrumentation
The screws are inserted in two or more consecutive levels to prevent motion at the segments that are being fused. It will be done using one of the two guidance technique depending on which arm the patient will be randomized to.
Active Comparator: Cervical distractor screws group
pedicle screws inserted using marker screws after posterior exposure of thoracolumbar /lumbar spine by either open midline posterior exposure or minimal invasive posterior wiltse style exposure with expandable tubular retractor, anatomical landmark for insertion of pedical screws identified and followed by inserting of a cervical distraction screw size 3 / 12 mm as a stable marker using high speed drill. C-arm floro is used to take antroposterior and lateral view to confirm the position of the marker screws at this stage.free hand technique supported by the images provided to cannulate the pedicle with the use of information on the images taken for all the marker screws simultaneously.
Procedure: Pedicle screws instrumentation
The screws are inserted in two or more consecutive levels to prevent motion at the segments that are being fused. It will be done using one of the two guidance technique depending on which arm the patient will be randomized to.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate screws breach
Time Frame: 6 months
Investigators will determine the rate of screws breach in the two comparison groups
6 months
Screw insertion time
Time Frame: 5 hours
screw insertion time in each technique which will be assessed by calculating the total time from puncture at the entry point by awl to complete all screw insertions into pedicles divided by the number of pedicle screws
5 hours
screws revision times
Time Frame: 6 months
investigators will determine which group needs more screws revision
6 months
degree of screws breach
Time Frame: 6 months
Investigators will determine degree of screws breach in the two comparison groups
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direction of the breach
Time Frame: 6 months
investigators will ascertain direction of the breach, if it is lateral ,medial , inferior , or superior.
6 months
complications
Time Frame: Up to 24 weeks
the two groups will be compared in rate of neurological or vascular complications.
Up to 24 weeks

Collaborators and Investigators

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

Sponsor

King Abdullah International Medical Research Center

Investigators

  • Principal Investigator: Mohammed A Khashab, MD, Assistant Professor of Orthopedic, College of Medicine, KSAU-HS

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 (Actual)

October 10, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

December 7, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • kashabmo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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