NCT04364295Enrolling By Invitation不适用
Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,285
- 试验地点
- 2
- 主要终点
- Evaluation of product failure
研究概览
简要总结
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.
详细描述
To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been treated with at least one SeaSpine product.
- •Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative.
- •Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care.
- •Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits.
排除标准
- •Was not implanted with at least one SeaSpine product during operation
- •Any other condition that the Investigator determines is unacceptable for enrollment into this registry
结局指标
主要结局
Evaluation of product failure
时间窗: 12 months post-operative
Product failure is defined as product fracture, loosening, gross migration and/or dissociation.
次要结局
- Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects(Intra-operative to 24 months)
研究者
研究点 (2)
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