Degenerative Spine Disease, Spinal Deformity
Conditions
Keywords
Spinal Surgery, Spinal Fusion, Deformity Correction, Spinal Instrumentation
Brief summary
To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.
Detailed description
The key objective of this observational registry is to prospectively collect data to facilitate the quantification of potential short- and long-term benefits of Renaissance-guided spine surgery. It establishes a common framework for collaboration between surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or open surgical approaches. The main endpoints that will be collected are surgical endpoints (e.g. complication rates), patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal alignment, mainly in reconstructive surgeries for spinal deformities) and technical parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).
Interventions
None listed
Sponsors
Mazor Robotics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Patients undergoing spinal surgery in a posterior approach where the surgeon used Renaissance surgical guidance system. Patient capable of complying with study requirements. Signed informed consent by patient.
Exclusion criteria
Any significant disease or disorder which, in the opinion of the Investigator, may either put the participant 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 cannot or will not sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes as measured on plain radiographs | Within 10 years of surgery | sagittal and coronal alignment in reconstructive surgeries for spinal deformities |
| Surgical complications | Within 10 years of surgery | new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss |
| Reoperation rates | Within 10 years of surgery | Any revision surgery on the segment of interest |
| Radiation exposure | Day of surgery | Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of convalescence | within 2 years of surgery | Length of hospital stay, destination at discharge, time to return to work, time to return to normal activities |
| Improvement in health-related quality of life metrics | up to 10 years post-operative | back and leg VAS, Oswestry Disability Index (ODI), SRS22, EQ-5D-5L, in accordance with the surgeon's practices |
| Clinical performance of instrumentation technique | Day of surgery | implant instrumentation time, total surgery time |
| Implant placement accuracy | Within one year post-surgery | Accuracy of implants as measured on a post-operative CT scan (when available) |
| Fusion rates/pseudoarthrosis | Within 1 year of surgery | The rate of fusion as determined within one year of surgical procedure. |
| Ratio of executed vs. planned screws | Day of surgery | Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause |
| Number of abandoned screws | Day of surgery | the number of screws not instrumented and the reason |
| Neuromonitoring events | Day of surgery | — |
Countries
United States
Outcome results
None listed