Prospective Robotic Global Research Study (PROGRESS)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lumbar Disc Disease
- Sponsor
- Globus Medical Inc
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Numeric Rating Scale
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Numeric Rating Scale
Time Frame: 24 months
Pain rating scale
SF-12
Time Frame: 24 months
12-Item short form health survey
Oswestry Disability Index
Time Frame: 24 months
Index derived from the Oswestry Low Back Pain Questionnaire
Screw Placement Accuracy
Time Frame: 2 weeks
Gertzbein Robbins Scale for screw accuracy
Complications
Time Frame: through study completion, 2 years
Adverse Event