To quantify potential short- and long-term benefits of robotically-guided minimally invasive (MIS) or open-approach spine surgery in adult patients undergoing multi-level spinal instrumentation surgery, in comparison to image- or navigation-guided instrumentation in a matching cohort of control patients, performed using a freehand technique, both in MIS and open approaches.
Study Type
OBSERVATIONAL
University of Kansas Medical Center
Kansas City, Kansas, United States
Incidence of surgical complications
New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss
Time frame: 1 year
Intraoperative radiation exposure
as measured by the C-arm, normalized per screw
Time frame: Day of operation
Revision surgeries
All cause revisions, including medical and surgical complications.
Time frame: 2 years
Deformity correction as measured on plain radiographs
Parameters of sagittal and coronal balance
Time frame: Within 2 years from surgery
Clinical outcome measures assessed using health-related quality of life questionnaires
Visual Analog Scale (VAS) back and leg, Oswestry Disability Index (ODI), SRS22 questionnaire, European Quality - 5 dimensions (EQ-5D-5L)
Time frame: up to 10 years post-operative
Pedicle screw instrumentation accuracy
Accuracy will be quantified in millimeters and scored using the Gertzbein Robbins classification, based on post-operative CTs that are clinically necessary for the management of the patient.
Time frame: Within 1 year of surgery
Length of convalescence
Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work
Time frame: Within 2 years of surgery
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Ratio of executed vs. planned screws
Number of screws planned to be robotically inserted but manually inserted instead, and cause.
Time frame: Day of surgery
Times of intra-operative stages
Instrumentation time per screw, total surgery time
Time frame: Day of surgery
Implant Failure
The implant failure rate as measured within one year post-surgery
Time frame: Within 1 year post-surgery
Number of Abandoned Screws
Number of screws intended to be instrumented with the robot and abandoned for cause.
Time frame: Day of surgery
Number of screws instrumented freehand
Number of screws planned to be instrumented robotically and instrumented freehand instead.
Time frame: Day of surgery
Clinical performance of instrumentation technique
Implant instrumentation time, length of surgery
Time frame: Day of surgery
Fusion rate/pseudoarthrosis
Fusion/pseudoarthrosis as measured within one year of surgery
Time frame: Within one year post-surgery
Neuromonitoring events
The number of clinically significant neuromonitoring events that may or may not lead to removal or reinstrumentation of the pedicle screw.
Time frame: Day of surgery