A Focused Registry on the Titanium Trochanter Fixation Nail Advanced (TFNAdvanced™) - TFNA System in Patients With Proximal Inter-, Per- or Subtrochanteric Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- The rate of mechanical and surgical complications defined as the number of
研究概览
简要总结
The aim of this project is the prospective data collection of a new device used for trochanteric fractures of the femur. It should be answered how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiological in terms of intra- and postoperative complications.
详细描述
In comparison to previous implants, the TFNA has been improved substantially. Therefore the purpose of this focused registry is to investigate how the newly developed implant called Trochanteric Fixation Nailing with anti-rotation feature (TFNA) is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.
All investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age 18 years and older
- •Pertrochanteric femoral fracture (31-A1 and 31-A2), intertrochanteric fracture (31-A3), fracture of the trochanteric area (31-A1/A2/A3) with diaphyseal extension or combined fracture of the trochanteric area and the femoral shaft (32-A/B/C) treated with the TFNA system according to the technique guide
- •Ability to understand the content of the patient information / informed consent form
- •Willingness and ability to participate in the registry according to the registry plan (RP)
- •Signed and dated IRB/EC-approved written informed consent or assent from a family member
排除标准
- •Additional acute fracture
- •Any not medically managed severe systemic disease
- •Recent history of substance abuse (i.e., recreational drugs, alcohol) that would preclude reliable assessment
- •Pregnancy or women planning to conceive within the registry period
- •Participation in any other medical device or medicinal product registry within the previous month that could influence the results of the present registry
- •Intraoperative decision to use implants other than the devices under investigation
结局指标
主要结局
The rate of mechanical and surgical complications defined as the number of
时间窗: up to 3 months
* cut out and cut through * secondary displacement of parts of the implant * breakage of the implant * iatrogenic fractures * surgical revisions * acute deep infection
次要结局
- OR time(Intraoperative)
- Fracture classification Classification(Baseline)
- Parker Mobility Score(up to 3 months)
- Quality of reduction and implant placement(up to 3 months)