Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up to Confirm Safety and Performance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 726
- 试验地点
- 4
- 主要终点
- Successful fixation or reconstruction of the midface without the need for unplanned revision surgery.
研究概览
简要总结
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the 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 Stryker's Facial iD UPC plating system when used in the 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 80 patients will be enrolled in the study. Additional patients may be enrolled up to 800 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful fixation or reconstruction of the midface 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
- •Patients who received a Stryker UPC plate for osteotomy, stabilization and rigid fixation of maxillofacial fractures or reconstruction as per routine clinical practice
- •Patients for whom data on the primary outcome variable is available.
排除标准
- •Patients with non-reducible and unstable fractures at the time of surgery
- •Patients with fractures of a severely atrophic mandible at the time of surgery
- •Patients with active local infections at the time of surgery
- •Patients with metal allergies and/or foreign body sensitivity at the time of surgery
- •Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery
- •Potentially non-compliant patients who are unwilling or incapable of following postoperative care instructions
结局指标
主要结局
Successful fixation or reconstruction of the midface without the need for unplanned revision surgery.
时间窗: Data collected at a single time point per patient in the course of 18 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
- Infection rate(Data collected at time points from patient medical charts in the course of 18 months.)
- Plate failure(Data collected at time points point per patient in the course of 18 months.)
- Hospitalization time; ICU and normal ward(Data collected at a single time point per patient in the course of 18 months.)
- Intraoperative complications(Data collected at a single time point per patient in the course of 18 months.)
- Postoperative complications(Data collected at time points per patient in the course of 18 months.)
- Any known adverse events(Data collected at time points per patient in the course of 18 months.)
- Satisfactory occlusion achieved after additional orthodontic treatment(Data collected at a single time point per patient in the course of 18 months.)
- Time to return to solid food/normal diet(Data collected at a single time point per patient in the course of 18 months.)
- EuroQol-5 Domain Questionnaire (if available)(Data collected at time points per patient in the course of 18 months.)
- Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available)(Data collected at time points per patient in the course of 18 months.)
- 12-Item Short Form Health Survey (SF-12)(Data collected at time points per patient in the course of 18 months.)