Prospective, Observational Registry of Renaissance-guided Spine Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 93
- 试验地点
- 4
- 主要终点
- Clinical outcomes as measured on plain radiographs
研究概览
简要总结
To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Clinical outcomes as measured on plain radiographs
时间窗: Within 10 years of surgery
sagittal and coronal alignment in reconstructive surgeries for spinal deformities
Surgical complications
时间窗: Within 10 years of surgery
new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss
Reoperation rates
时间窗: Within 10 years of surgery
Any revision surgery on the segment of interest
Radiation exposure
时间窗: Day of surgery
Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room
次要结局
- Implant placement accuracy(Within one year post-surgery)
- Clinical performance of instrumentation technique(Day of surgery)
- Ratio of executed vs. planned screws(Day of surgery)
- Number of abandoned screws(Day of surgery)
- Neuromonitoring events(Day of surgery)
- Length of convalescence(within 2 years of surgery)
- Improvement in health-related quality of life metrics(up to 10 years post-operative)
- Fusion rates/pseudoarthrosis(Within 1 year of surgery)