Degenerative Lumbar Spinal Stenosis
Conditions
Brief summary
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.
Interventions
DEVICERenaissance, Mazor Robotics Ltd, Caesare, Israel
Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot
PROCEDUREfree hand technique
No specific device is necessary in the free hand technique
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients (age from 40 years to 85 years), undergoing short (below 3 consecutive vertebrae) lumbar or lumbosacral fixation surgery. * Primary surgery and revision surgery * Patient capable of complying with study requirements * Signed informed consent of patient or legal guardian
Exclusion criteria
* Infection or malignancy * Primary abnormalities of bones (e.g. osteogenesis imperfecta) * Primary muscle diseases, such as muscular dystrophy * Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, neurofibroma) * Spinal cord abnormalities with any neurologic symptoms or signs * Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia * Paraplegia * Patients requiring anterior release or instrumentation * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study. * Patient cannot follow study protocol, for any reason * Patient (or legal guardian, when applicable) cannot or will not sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pedicle screw instrumentation accuracy | within 7 days after operation | The location of pedicle screw is evaluated by postoperative CTs in a subset of patients |
| Oswestry Disability Index | up to 5 year after operation, every year | Health status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | after operation | intraoperative blood loss |
| postoperative drainage | within 3 days after operation | Total drainage after surgery |
| amount of transfusion | within 7 days after operation | Total transfusion during and after surgery |
| time to ambulation | within 3 days after operation | immediate postop to ambulation start |
| Fusion rates | up to 5 year after operation | This is assessed by postoperative computed tomography at 1 year after surgery |
| Visual Analog Pain Scale | up to 5 year after operation, every year | Pain status |
| SF-36 | up to 5 year after operation, every year | Health status |
| Radiographic adjacent level degeneration | up to 5 year after operation, every year | Radiographic changes according to UCLA, vertebral body translation, motion change, segmental kyphosis or lordosis, disc height changes |
| Change of Oswestry Disability Index | up to 5 year after surgery, every year | Health status |
| Operation duration | After operation | Intraoperative time |
Countries
South Korea
Outcome results
None listed