Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures
研究概览
简要总结
The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel results to XLIF® single or multilevel results relative to the safety endpoints. This study will collect retrospective data on subjects who were treated with VEO® and XLIF® at least 3 months prior to the initiation of this study. Given that fusion generally takes at least 6 months to determine, the aim of this study is not to determine fusion but to consider the short-term (out to 6 months) reported adverse events between the two cohorts.
Devices used in both systems are cleared for use and conform to US regulatory requirements. The study employs these procedures and devices for uses that are consistent with their 510(k), legally cleared, labeling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult 18 years of age or older;
- •Male or female VEO® subjects that had previously received the single or two level LLIF procedure using the VEO® or XLIF® systems as an adjunct to fusion at L2-S1 to treat degenerative disc disease (DDD) at the treated level;
- •Subject that was treated no less than 3 months prior to this evaluation with the LLIF procedure using the VEO® or XLIF® system by the participating surgeons.
排除标准
- •Subject who did not receive LLIF procedure using the VEO® or XLIF® system for fusion of L2-S1;
- •Subjects with less than 3 months of follow-up data.
结局指标
主要结局
Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures
时间窗: Observed for up to 6 months post-surgery
Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.
次要结局
- Safety(Observed for up to 6 months post-surgery)