Degenerative Spine Disease, Spondylolisthesis, Spondylosis
Conditions
Keywords
Robotic-guided surgery, Minimally invasive spinal surgery, Spinal fusion, Pedicle screws
Brief summary
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.
Interventions
None listed
Sponsors
Mazor Robotics
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients (age over 21 years), undergoing short (4 or less consecutive vertebrae) lumbar or lumbosacral percutaneous/MIS spinal fixation surgery. 2. May include surgeries involving iliac screws, although these screws will not be included in the data analysis. 3. Primary fusion surgery 4. Patient capable of complying with study requirements 5. Signed informed consent by patient
Exclusion criteria
1. Pregnancy 2. Revision surgery (prior laminectomy or discectomy is not excluded). 3. Infection or malignancy 4. Primary abnormalities of bones (e.g. osteogenesis imperfecta) 5. Primary muscle diseases, such as muscular dystrophy 6. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida or neurofibroma) 7. Spinal cord abnormalities with any neurologic symptoms or signs 8. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia 9. Paraplegia 10. Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery 11. Patients requiring anterior release or instrumentation 12. 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. 13. Patient cannot follow study protocol, for any reason 14. Patient cannot or will not sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative exposure to x-ray radiation | Day of surgery | Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room. |
| Surgical complications | Within first year from day of surgery | New neural deficits, implant-related durotomy, infection requiring return to surgery, hardware failure requiring removal, vertebral body fracture, failure to fuse |
| Revision surgeries | 1 year | All cause revisions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Times of intra-operative stages | Day of surgery | instrumentation time per screw, total surgery time |
| Pedicle screw instrumentation accuracy | Within 1 year of surgery, if indicated by surgeon and clinically necessary | 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. |
| Quality of life assessment | Each visit up to 1 year1 | Health related quality of life questionnaires, including: back and leg Visual Analog Scale (VAS), Oswestry Disability Index (ODI), European Quality % Dimensions (EQ-5D-5L) |
| Ratio of executed vs. planned screws | Day of surgery | number of screws planned to be robotically inserted and manually inserted instead and cause. |
| Incidence of pseudoarthrosis (malunion) | Within 1 year from surgery | Failure of the operated spinal segment to fuse. |
| Length of convalescence | Within 1 year of surgery | Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work |
Countries
United States
Outcome results
None listed