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

NCT04196153 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-09-07

No results posted yet for this study

Summary

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.

Conditions

  • Pedicle Screws
  • Surgery, Computer-Assisted/Adverse Effects
  • Bone Screws
  • Imaging, Three-Dimensional/Methods

Interventions

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.

Sponsors & Collaborators

  • King Abdullah International Medical Research Center

    lead OTHER

Principal Investigators

  • Mohammed A Khashab, MD · Assistant Professor of Orthopedic, College of Medicine, KSAU-HS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2021-09-30
Completion
2021-10-31

Countries

  • Saudi Arabia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04196153 on ClinicalTrials.gov