Prospective, Observational Registry of Renaissance-guided Spine Surgeries

Study Overview
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Brief Summary
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To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.

Detailed Description
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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).

Official Title
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Prospective, Observational Registry of Renaissance-guided Spine Surgeries

Conditions
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Degenerative Spine Disease, Spinal Deformity

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes as measured on plain radiographs | sagittal and coronal alignment in reconstructive surgeries for spinal deformities | Within 10 years of surgery | 
| Surgical complications | new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss | Within 10 years of surgery | 
| Reoperation rates | Any revision surgery on the segment of interest | 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 | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of instrumentation technique | implant instrumentation time, total surgery time | Day of surgery | 
| Ratio of executed vs. planned screws | Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause | Day of surgery | 
| Number of abandoned screws | the number of screws not instrumented and the reason | Day of surgery | 
| Neuromonitoring events |  | Day of surgery | 
| Length of convalescence | Length of hospital stay, destination at discharge, time to return to work, time to return to normal activities | 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 | up to 10 years post-operative | 
| Fusion rates/pseudoarthrosis | The rate of fusion as determined within one year of surgical procedure. | Within 1 year of surgery | 
| Implant placement accuracy | Accuracy of implants as measured on a post-operative CT scan (when available) | Within one year post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Surgery, Spinal Fusion, Deformity Correction, Spinal Instrumentation