To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.
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).
Study Type
OBSERVATIONAL
Enrollment
93
Lyerly Baptist/ Lyerly Neurosurgery
Jacksonville, Florida, United States
Tabor Orthopedics
Memphis, Tennessee, United States
Spine Associates
Houston, Texas, United States
The Virginia Spine Institute
Reston, Virginia, United States
Clinical outcomes as measured on plain radiographs
sagittal and coronal alignment in reconstructive surgeries for spinal deformities
Time frame: Within 10 years of surgery
Surgical complications
new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss
Time frame: Within 10 years of surgery
Reoperation rates
Any revision surgery on the segment of interest
Time frame: Within 10 years of surgery
Radiation exposure
Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room
Time frame: Day of surgery
Clinical performance of instrumentation technique
implant instrumentation time, total surgery time
Time frame: Day of surgery
Ratio of executed vs. planned screws
Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause
Time frame: Day of surgery
Number of abandoned screws
the number of screws not instrumented and the reason
Time frame: Day of surgery
Neuromonitoring events
Time frame: Day of surgery
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Length of convalescence
Length of hospital stay, destination at discharge, time to return to work, time to return to normal activities
Time frame: within 2 years of surgery
Improvement in health-related quality of life metrics
back and leg VAS, Oswestry Disability Index (ODI), SRS22, EQ-5D-5L, in accordance with the surgeon's practices
Time frame: up to 10 years post-operative
Fusion rates/pseudoarthrosis
The rate of fusion as determined within one year of surgical procedure.
Time frame: Within 1 year of surgery
Implant placement accuracy
Accuracy of implants as measured on a post-operative CT scan (when available)
Time frame: Within one year post-surgery