Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 41medical AG
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Occurrence of AEs/SAEs in the affected lower extremity/extremities
研究概览
简要总结
The goal of this observational multicenter case series is to assess the safety and performance of the CE-marked "Biphasic Plate Distal Femur" during standard of care.
详细描述
The goal of this observational study is to assess the safety and performance of the CE-marked "Biphasic Plate Distal Femur" during standard of care. The study is conducted as a retrospective and prospective multicenter case series. Eligible patients are those with fractures of the distal femur who are treated with the Biphasic Plate DF according to the Instruction for Use (IFU). The patient will be followed-up until healing or up to 12 months, whichever comes first.
To assess the safety and performance following data is collected:
- incidents of AEs/SAEs occurring in the affected lower extremity/extremities
- Bone healing assessed by a surgeon
- Weightbearing and function
- Patients' quality of life and pain level
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with fractures of the distal femur requiring internal fixation and treated with the Biphasic Plate DF as indicated according to the IFU. As per the IFU, the Biphasic Plate DF is indicated for:
- •Distal shaft fractures
- •Supracondylar fractures
- •Intraarticular fractures
- •Periprosthetic fractures
- •No other major implant beside the Biphasic Plate DF is used for fixation of the distal femur fracture, with the exceptions of lag screw(s) and/or cerclage wire(s), and/or a joint replacement.
- •Patients who are willing and able to comply with postoperative FUs per local standard of care.
- •Ability to provide informed consent according to the IRB/EC defined and approved procedures.
- •Patients over 18 years of age
排除标准
- •(preoperatively):
- •Patient is participating in another interventional clinical trial.
- •Exclusion Criteria (intraoperatively):
- •Change of surgical plan intraoperatively at the discretion of the surgeon that Biphasic Plate DF is not used
- •Necessity to apply a second (medial) plate (double plating) or an intramedullary nail in case of critical fixation distally
结局指标
主要结局
Occurrence of AEs/SAEs in the affected lower extremity/extremities
时间窗: until clinically healed or up to 12 months
The primary outcome measure is the occurrence of AEs/SAEs in the affected lower extremity/extremities that are deemed related, probably related, or possibly related to the surgical procedure or the Biphasic Plate DF
次要结局
- Bone Healing(until clinically healed or up to 12 months)
- Patient-reported outcome measures(until clinically healed or up to 12 months)