Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up to Confirm Safety, Performance and Effectiveness of The Universal CMF System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery
研究概览
简要总结
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.
详细描述
This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of the Stryker Universal System when used in a clinical setting. This study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. Based on a non-inferiority study power calculation a minimum of 120 patients will be enrolled in the study. Additional patients may be enrolled up to 150 subjects depending on site enrolment rate and patient availability. Up to 2 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature patients at the time of surgery.
- •Patients who underwent a craniomaxillofacial procedure using implants of the Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System as per routine clinical practice.
- •Patients for whom data on the primary outcome variable is available.
- •Patients with data available from follow-up visits.
排除标准
- •Patients with active infections at the time of surgery.
- •Patients with known metal allergies and/or foreign body sensitivity at the time of surgery.
- •Subjects with non-reducible and unstable fractures (except reconstruction plates) at the time of surgery that were treated with the subject devices.
- •Patients who underwent secondary reconstructions with non-secondary reconstruction plates
- •Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery.
结局指标
主要结局
Successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery
时间窗: Data collected at a single time point per patient in the course of 12 months.
Assessed by reviewing adverse events in patient medical charts at time point after surgery. Used to document whether an unplanned revision surgery was required or not for patients.
Successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery
时间窗: Data collected at a single time point per patient in the course of 12 months.
Assessed by reviewing adverse events in patient medical charts at time point after surgery. Used to document whether an unplanned revision surgery was required or not for patients.
次要结局
- Intraoperative complications(Data collected at a single time point per patient in the course of 12 months.)
- Postoperative complications(Data collected at time points per patient in the course of 12 months.)
- Any known adverse events potentially related to the primary outcome objective and/or device(Data collected at time points per patient in the course of 12 months.)
- Implant failure(Data collected at time points point per patient in the course of 12 months.)
- Operating room (OR) time(Data collected at a single time point per patient in the course of 12 months.)
- Hospitalization time(Data collected at a single time point per patient in the course of 12 months.)
- Post-operative bone consolidation(Data collected at time points point per patient in the course of 12 months.)
- Intraoperative complications(Data collected at a single time point per patient in the course of 12 months.)
- Postoperative complications(Data collected at time points per patient in the course of 12 months.)
- Any known adverse events potentially related to the primary outcome objective and/or device(Data collected at time points per patient in the course of 12 months.)
- Implant failure(Data collected at time points point per patient in the course of 12 months.)
- Operating room (OR) time(Data collected at a single time point per patient in the course of 12 months.)
- Hospitalization time(Data collected at a single time point per patient in the course of 12 months.)
- Post-operative bone consolidation(Data collected at time points point per patient in the course of 12 months.)