Stryker Customized Plates for Mandibular Reconstruction: A Retrospective Post Market Follow Up to Confirm Safety and Performance of Surgeon iD Mandible Reconstruction Plates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Rate of successful reconstruction of the mandible without the need for unplanned revision surgery compared to benchmark devices in scientific literature.
研究概览
简要总结
A retrospective post market follow up to confirm safety and performance of Stryker's Surgeon iD Plates (SMRP) medical device. 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 Surgeon iD Mandible Recon Plate 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 27 patients will be enrolled in the study. Additional patients may be enrolled up to 80 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States and one in the EU will participate in this study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be assessed at all available follow-up timepoints for 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 underwent primary or secondary mandibular reconstruction using a Stryker Surgeon iD Plate implant as per routine clinical practice.
- •Patients for whom data on the primary outcome variable is available.
排除标准
- •Patients with active local infections at the time of surgery.
- •Patients with known metal allergies and/or foreign body sensitivity at the time of surgery.
- •Potentially non-compliant patients who were unwilling or incapable of following post-operative care instructions.
- •Patients with inadequate bone quantity or quality necessary for plate fixation or stabilization at the time of surgery
结局指标
主要结局
Rate of successful reconstruction of the mandible without the need for unplanned revision surgery compared to benchmark devices in scientific literature.
时间窗: Data collected at a single time point per patient in the course of 12 months
Rate of unplanned revision surgery determined by reviewing adverse events in patient medical charts after surgery. Used to document whether an unplanned revision surgery was required or not for each patient.
次要结局
- Time to return to solid food/normal diet(Data collected at a single time point per patient in the course of 12 months.)
- Rate of satisfactory occlusion achieved with orthodontic treatment.(Data collected at time points per patient in the course of 12 months.)
- Hospitalization time: ICU and normal ward(Data collected at a single time point per patient in the course of 12 months.)
- Short-form-12-health-survey-questionnaire (if available)(Data collected at time points per patient in the course of 12 months.)
- Ischemia time(Data collected at a single time point per patient in the course of 12 months.)
- EuroQol-5 Domain Questionnaire (if available)(Data collected at time points per patient in the course of 12 months.)
- Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available)(Data collected at time points per patient in the course of 12 months.)
- Infection rate(Data collected at time points from patient medical charts 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(Data collected at time points per patient in the course of 12 months.)
- Rate of Plate failure(Data collected at time points 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.)