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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The ExcelsiusGPS™ is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (pre-operative CT, intra-operative CT and fluoroscopy), using a dynamic reference base and positioning camera.
Southeastern Spine Institute
Mt. Pleasant, South Carolina, United States
RECRUITINGNumeric Rating Scale
Pain rating scale
Time frame: Baseline
Numeric Rating Scale
Pain rating scale
Time frame: 2 weeks
Numeric Rating Scale
Pain rating scale
Time frame: 3 months
Numeric Rating Scale
Pain rating scale
Time frame: 6 months
Numeric Rating Scale
Pain rating scale
Time frame: 12 months
Numeric Rating Scale
Pain rating scale
Time frame: 24 months
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Time frame: Baseline
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Time frame: 2 weeks
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Time frame: 3 months
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Time frame: 12 months
Oswestry Disability Index
Index derived from the Oswestry Low Back Pain Questionnaire
Time frame: 24 months
SF-12
12-Item short form health survey
Time frame: Baseline
SF-12
12-Item short form health survey
Time frame: 2 weeks
SF-12
12-Item short form health survey
Time frame: 3 months
SF-12
12-Item short form health survey
Time frame: 6 months
SF-12
12-Item short form health survey
Time frame: 12 months
SF-12
12-Item short form health survey
Time frame: 24 months
Screw Placement Accuracy
Gertzbein Robbins Scale for screw accuracy
Time frame: 2 weeks
Complications
Adverse Event
Time frame: through study completion, 2 years