The purpose of this study was to quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar or lumbosacral spine disease in adult patients, in comparison to instrumentation in a matching cohort of control patients performed using conventional freehand technique.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot
No specific device is necessary in the "free hand technique"
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Pedicle screw instrumentation accuracy
The location of pedicle screw is evaluated by postoperative CTs in a subset of patients
Time frame: within 7 days after operation
Oswestry Disability Index
Health status
Time frame: up to 5 year after operation, every year
Fusion rates
This is assessed by postoperative computed tomography at 1 year after surgery
Time frame: up to 5 year after operation
Operation duration
Intraoperative time
Time frame: After operation
intraoperative blood loss
intraoperative blood loss
Time frame: after operation
postoperative drainage
Total drainage after surgery
Time frame: within 3 days after operation
amount of transfusion
Total transfusion during and after surgery
Time frame: within 7 days after operation
time to ambulation
immediate postop to ambulation start
Time frame: within 3 days after operation
Change of Oswestry Disability Index
Health status
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 5 year after surgery, every year
Visual Analog Pain Scale
Pain status
Time frame: up to 5 year after operation, every year
SF-36
Health status
Time frame: up to 5 year after operation, every year
Radiographic adjacent level degeneration
Radiographic changes according to UCLA, vertebral body translation, motion change, segmental kyphosis or lordosis, disc height changes
Time frame: up to 5 year after operation, every year