Kyphoscoliosis, Kyphosis, Scoliosis, Spinal Deformity, Spondylosis
Conditions
Keywords
Robotic-guided spinal fusions, Scoliosis, Kyphoscoliosis, Spinal deformity, Spondylosis
Brief summary
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.
Interventions
None listed
Sponsors
Mazor Robotics
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients (age 21 years and older), undergoing long (5 consecutive vertebrae or more) spinal fusion surgery, between T1 to the sacrum. 2. Cases may include surgeries involving iliac screws (e.g., Galveston technique or S2AI screws) although these screws will not be included in the data analysis. 3. Cases may include augmented cases (when one or more of the screws are inserted into vertebrae after a vertebral augmentation procedure, such as kyphoplasty or vertebroplasty). 4. Patient capable of complying with study requirements 5. Signed informed consent by patient
Exclusion criteria
1. Infection or malignancy 2. Primary abnormalities of bones (e.g. osteogenesis imperfecta) 3. Primary muscle diseases, such as muscular dystrophy 4. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma) 5. Spinal cord abnormalities with any neurologic symptoms or signs 6. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia 7. Paraplegia 8. Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery 9. 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. 10. Pregnancy 11. Patient cannot follow study protocol, for any reason 12. Patient cannot or will not sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical complications | 1 year | New neural deficits, implant-related durotomy, infection requiring surgery, excessive blood loss |
| Intraoperative radiation exposure | Day of operation | as measured by the C-arm, normalized per screw |
| Revision surgeries | 2 years | All cause revisions, including medical and surgical complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Times of intra-operative stages | Day of surgery | Instrumentation time per screw, total surgery time |
| Implant Failure | Within 1 year post-surgery | The implant failure rate as measured within one year post-surgery |
| Number of Abandoned Screws | Day of surgery | Number of screws intended to be instrumented with the robot and abandoned for cause. |
| Number of screws instrumented freehand | Day of surgery | Number of screws planned to be instrumented robotically and instrumented freehand instead. |
| Clinical performance of instrumentation technique | Day of surgery | Implant instrumentation time, length of surgery |
| Clinical outcome measures assessed using health-related quality of life questionnaires | up to 10 years post-operative | Visual Analog Scale (VAS) back and leg, Oswestry Disability Index (ODI), SRS22 questionnaire, European Quality - 5 dimensions (EQ-5D-5L) |
| Pedicle screw instrumentation accuracy | Within 1 year of surgery | 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. |
| Length of convalescence | Within 2 years of surgery | Length of stay at the hospital, destination at discharge, time to return to normal activities, time to return to work |
| Neuromonitoring events | Day of surgery | The number of clinically significant neuromonitoring events that may or may not lead to removal or reinstrumentation of the pedicle screw. |
| Deformity correction as measured on plain radiographs | Within 2 years from surgery | Parameters of sagittal and coronal balance |
| Fusion rate/pseudoarthrosis | Within one year post-surgery | Fusion/pseudoarthrosis as measured within one year of surgery |
| Ratio of executed vs. planned screws | Day of surgery | Number of screws planned to be robotically inserted but manually inserted instead, and cause. |
Countries
United States
Outcome results
None listed