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Prospective Robotic Global Research Study (PROGRESS)

Prospective Robotic Global Research Study (PROGRESS)

Recruiting
18-85 years
All
Phase N/A

Overview

The purpose of this study is to prospectively review outcomes of patients who have surgery with the ExcelsiusGPS robotics system in order to analyze screw placement accuracy. Patient demographics, intraoperative data and radiographic imaging to determine screw placement accuracy will be collected and reviewed. This information will be compared in a separate study to retrospectively collected data from sites who have done a similar number of cases without the robot.

Eligibility

Inclusion Criteria:

  • At least 18 years of age and a maximum age of 85 years
  • Require surgery that includes posterior stabilization with screws to be inserted in cervical, thoracic, lumbar spine or sacrum
  • Able to sign Informed Consent

Exclusion Criteria:

  • Previous fusion or fusion attempt at index level(s)
  • DEXA score of -2.5 or below (only if clinically indicated - optional)
  • Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
  • History of substance abuse (drugs or alcohol)
  • Mentally incompetent or prisoner
  • Worker's compensation
  • Pregnant or intention to become pregnant

Study details
    Lumbar Disc Disease

NCT04257279

Globus Medical Inc

16 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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