To quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.
Study Type
OBSERVATIONAL
Enrollment
600
Florida Hospital Celebration Health
Celebration, Florida, United States
Baptist Health
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Central Florida Neurosurgery Institute
Intra-operative exposure to x-ray radiation
Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room.
Time frame: Day of surgery
Surgical complications
New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse
Time frame: Within first year from day of surgery
Revision surgeries
All cause revisions
Time frame: 1 year
Pedicle screw instrumentation accuracy
Accuracy will be quantified in millimeters and scored using the Gertzbein-Robbins classification, based on postoperative CTs that are clinically necessary for the management of the patient.
Time frame: Within 1 year of surgery, if indicated by surgeon and clinically necessary
Incidence of pseudoarthrosis (malunion)
Failure of the operated spinal segment to fuse.
Time frame: Within 1 year from 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 1 year of surgery
Times of intra-operative stages
instrumentation time per screw, total surgery time
Time frame: Day of surgery
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Orlando, Florida, United States
Southeastern Spine Center & Research Institute
Sarasota, Florida, United States
The Rothman Institute
Abington, Pennsylvania, United States
Tabor Orthopedics
Memphis, Tennessee, United States
Atlantic Brain & Spine
Fairfax, Virginia, United States
Virginia Spine Institute
Reston, Virginia, United States
Ratio of executed vs. planned screws
number of screws planned to be robotically inserted and manually inserted instead and cause.
Time frame: Day of surgery
Quality of life assessment
Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L)
Time frame: Each visit up to 1 year1