A Prospective Study Evaluating Trochanteric Fixation Nail Advanced (TFNA) in a Chinese Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Synthes GmbH
- 入组人数
- 188
- 试验地点
- 9
- 主要终点
- Successful Fracture Union Rate 24 Weeks After Surgery
研究概览
简要总结
This is a prospective, multicenter, randomized, controlled, two-arm, non-inferiority study which will be conducted in China to support registration of a cephalomedullary nailing system (TFNA) that currently is available globally. The study will compare the safety and the effectiveness of two intramedullary nails (the investigational group is TFNA and the control group is PFNA-II).Patients enrolled at each site will be randomized in a ratio of 1:1, i.e. one patient assigned to surgery implanted with TFNA for each patient assigned to PFNA-II. Separate block randomization schedules within each site will be used to ensure equal distribution of treatment and control patients. Up to 15 centers will be approved to participate in this study.
Patient will be clinically followed after surgery at 1, 6, 12 and 24 weeks. The data up to and including 24 week follow up visit will be used in determining the primary safety and effectiveness of the TFNA.
The primary objective of this study is to evaluate whether fracture union rate, evaluated 24 weeks after proximal femur fracture, for the investigational TFNA intramedullary nail is non-inferior to that for currently available control product PFNA-II in patients with proximal femur fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Only patient is masked during the study. He/she will be notified during inform consent that either treatment will be used but they will not be informed exactly which group.
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
- •Patients with unilateral proximal femur fractures that will be treated with intramedullary nail internal fixation
- •According to AO fracture classification, subjects with following fracture type:
- •Pertrochanteric (31-A1 and 31-A2)
- •Intertrochanteric (31-A3)
- •Trochanteric area (31-A1/A2/A3) with diaphyseal extension
- •Subject must be comfortable with speaking and understanding questions and responses in an available translated language for patient reported outcomes (PROs)
排除标准
- •Subject does not provide voluntary consent to participate in the study
- •The subject is a woman who is pregnant or lactating
- •Fractures where the operative treatment will occur more than three weeks after the primary injury
- •Patients with femoral head fractures and femoral neck fractures (AO classification 31-B and 31-C)
- •Pathological fracture (e.g., primary or metastatic tumor)
- •Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined vascular injury, and combined osteofascial compartment syndrome
- •Multiple systemic injuries judged by researchers not suitable for enrollment, or orthopaedic fractures in other bones at three or more sites
- •Revision surgeries (for example, due to malunion, nonunion or infection)
- •Concurrent medical conditions judged by researchers not suitable for enrollment, such as: diabetes, metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc
- •Patients with anaesthetic and surgical contraindications
- •Patients known to be allergic to implant components
- •Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months)
- •Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse);
- •Patients participated into other clinical trial in the previous 3 months;
- •Patients with bad compliance judged by researchers and cannot complete the test according to test scheme, such as schizophrenia and dementia.
结局指标
主要结局
Successful Fracture Union Rate 24 Weeks After Surgery
时间窗: 24 weeks
The number of achieving fracuture union at 24 weeks of each group will be counted and the percentage will be calculated. Fracture union success is a composite endpoint; in order for an individual subject's surgery implanted with TFNA or PFNA-II to be considered successful he/she must satisfy all of the following criteria: 1. No focal tenderness or lengthwise percussion pain, or abnormal movement 2. The frontal/lateral X-ray examination shows the vague or no fracture gap, or the continuous callus passing across the fracture line 3. No deformation or breakage is found in the test product
次要结局
未报告次要终点