Prospective Robotic Global Research Study (PROGRESS)

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Globus Medical Inc
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Updated on 16 February 2024
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Summary

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.

Details
Condition Lumbar Disc Disease
Age 18years - 85years
Treatment ExcelsiusGPS™
Clinical Study IdentifierNCT04257279
SponsorGlobus Medical Inc
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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