Stryker Customized Plates for Mandibular Reconstruction: A Retrospective Post Market Follow Up to Confirm Safety and Performance of Facial iD Customized Mandible Reconstruction Plates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of successful reconstruction of the mandible without the need for unplanned revision surgery
研究概览
简要总结
A retrospective post market follow up to confirm the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction. 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 Customized Plates for Mandibular Reconstruction (CMRP) in the clinical setting. his study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. Up to 3 investigational sites in US will be participating. Based on a non-inferiority study power calculation 80 subjects will be enrolled in the study. The primary outcome parameter evaluating successful reconstruction of the mandible 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 underwent primary or secondary mandibular reconstruction using a Stryker Facial iD CMRP 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
时间窗: Data collected at a single time point per patient in the course of 16 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
- Hospitalization time: ICU and normal ward(Data collected at a single time point per patient in the course of 16 months.)
- Ischemia time(Data collected at a single time point per patient in the course of 16 months.)
- Frequency of Maxilla-mandibular fixation(Data collected at time points per patient in the course of 16 months.)
- Rate of satisfactory occlusion achieved with orthodontic treatment.(Data collected at a single time point per patient in the course of 16 months.)
- Infection rate(Data collected at time points from patient medical charts in the course of 16 months.)
- Intraoperative complications(Data collected at a single time point per patient in the course of 16 months.)
- Postoperative complications(Data collected at time points per patient in the course of 16 months.)
- Any known adverse events(Data collected at time points per patient in the course of 16 months.)
- Rate of plate or screw failure(Data collected at time points point per patient in the course of 16 months.)
- Operating room (OR) time(Data collected at a single time point per patient in the course of 16 months.)
- Time to return to solid food/normal diet(Data collected at a single time point per patient in the course of 16 months.)
- Misfit of implant(Data collected at time points per patient in the course of 16 months.)
- EuroQol-5 Domain Questionnaire (if available)(Data collected at time points per patient in the course of 16 months.)
- Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available)(Data collected at time points per patient in the course of 16 months.)
- 12-Item Short Form Health Survey (SF-12)(Data collected at time points per patient in the course of 16 months.)
- Visual Analogue Scale (VAS) Pain(Data collected at time points per patient in the course of 16 months.)
- End user questionnaire(Data collected during the course of 16 months.)