Spinal Disease
Conditions
Keywords
Robotic-guided spine surgery
Brief summary
This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.
Detailed description
What is the impact on clinical and patient-reported outcomes for participants who undergo robot assisted surgery? This will be the first multi-center study to prospectively collect data on robotic assisted spine surgery outcomes. The primary objective of this study will be to facilitate quantification of potential short- and long-term benefits of robotically guided spine surgeries. It is hypothesized that use of robotic guidance during spinal instrumentation will have numerous short- and long-term benefits to both participant and surgeon. Expected benefits include improved surgical and clinical outcomes, lower incidence of procedure-related adverse events (e.g., fewer new neurological deficits, implant-related durotomies, and implant misplacements), improved implant accuracy, lower intraoperative radiation exposure, and lower reoperation rates, when compared to the published literature. The secondary objective of this study is to assess the clinical performance of robotic instrumentation as per the pre-operative plan. To this end, data on a number of common clinical metrics will be analyzed to determine the extent to which they are affected by the use of robotic guidance during implantation.
Interventions
PROCEDURERobotic-guided spine surgery
The Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery.
Sponsors
Medtronic
The National Spine Health Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Any pediatric, adolescent or adult patient * Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology.
Exclusion criteria
* Pregnancy * active infection * malignancy * primary abnormalities of bone * primary muscle diseases (e.g., muscular dystrophy) * neurologic diseases * spinal cord abnormalities/lesions * paraplegia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the success of robotic-guided spine surgery, by the radiation exposure. | 1 year after surgery | To determine radiation exposure to the patient and surgeon. |
| To evaluate the success of robotic-guided spine surgery, from planning to execution. | 1 year after surgery | To evaluate the success from planning to execution of robotic screw placement. |
| To evaluate the success of robotic-guided spine surgery, by screw placement accuracy. | 1 year after surgery | To determine screw accuracy |
| To evaluate the success of robotic-guided spine surgery, by revision surgery rates. | 1 year after surgery | To determine the rate of revision surgery due to symptomatic screw malposition within 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate clinical outcomes, as determined by all cause revisions | 1 year after surgery | To determine the rate of revision surgery for all causes within 1 year |
| To evaluate clinical outcomes, by surgical complications | 1 year after surgery | To determine the rate of surgical complications (wound infection/dehiscence, major neurological deficit, hemorrhage, dural tear) |
| To evaluate clinical outcomes, by patient reported outcome measures | 1 year after surgery | To evaluate for changes in Patient Reported Outcomes Measurement Information System (PROMIS) scores over 1 year; (PROMIS scores are calculated at T-scores on a 0-100 point scale - for positively worded functions, such as physical function and global health, the higher the score the better the outcome; but for negatively worded functions, like pain interference, the higher the score the worse the outcome). |
| To evaluate clinical outcomes, by patient disability rating | 1 year after surgery | To evaluate for changes in Oswestry Disability Index (ODI) scores over 1 year; disability scores range from 0-100, the higher the score the worse the outcome/disability. |
Countries
United States
Outcome results
None listed