Post Market Clinical follow-Up Study to evaluate the safety and performance of femoral neck system, dynamic hip system or cannulated cancellous screws in patient with femoral neck fracture
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- 3.To asses the safety and performance of Cannulated cancellous screws till 1 year follow-up.
研究概览
简要总结
The Femur is the longest and largest bone in the body with abundant blood supply.The Femoral neck fractures occur in 2 to 3 % of skeletal injuries. Femoral Neck fractures(FNF) are widespread orthopedic injury which results in morbidity and mortality. Femoral neck fractures are very common in old age people but treatment of FNF in relatively young patients deserve attention.Femoral neck fractures usually occur by high- energy trauma, that is, fall from high places or high speed accident.The goal of the treatment in young patient is to retain the femoral neck fracture as much as possible to avoid necrosis of femoral head and achieve bone healing. There are about 4 types of distinct patterns as per the Garden fracture classification coded as Type I,II,III and IV.Interventions include surgical treatment of these fractures which lead to reduced mortality and complications. The implants used in surgical treatment for femoral neck fracture are Femoral Neck System, Dynamic Hip System and Cannulated Cancellous Screws.
Our Femoral Neck System, Dynamic Hip System and Cannulated Cancellous Screw based on the equivalence of design, production and final product inspection with the predicate device K100238 DEPUY ORTHOPAEDICS, INC DePuy Synthes and is being marketed nationally and globally from the year 2015. No serious adverse effects or complaints have been received till date for the systems.
As a manufacturer, Auxein has planned to conduct a Post-marketing clinical follow-up (PMCF) study following the CE marking of the device (Femoral neck System, Dynamic Hip System and Cannulated Cancellous Screw) marketed for its intended use and aims to verify the clinical performance and safety of the implant. We are conducting a prospective post-marketing surveillance study with 1 year post-operative follow-up to update the clinical performance and outcome of our device. Such studies are required by the regulatory authorities for all medical device implants that do not have medium to long-term clinical evidence available at the time of gaining approval to market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject is willing and able to give informed consent for participation in the study.
- •2.Male and female above 18 years to 55 year skeletally mature patients.
- •3.Subject with Femoral Neck Fracture of III and IV class (Garden Classiï¬cation) schedule for FNF surgery.
排除标准
- •1.Pathological fractures,open fractures or other fractures including poly- trauma, stress fractures of the femoral neck 2.Local infection in the hip joint before the ï¬xation surgery.
- •3.Patient with previously diagnosed osteoporosis.
- •Fracture-dislocation of the femoral neck and hip joint.
- •4.Likely problems, in the judgement of the attending surgeon, with maintaining follow up.
- •5.Patients with severe mental disorders and 6.psychotropic drug addictions.
- •7.Pregnancy.
结局指标
主要结局
3.To asses the safety and performance of Cannulated cancellous screws till 1 year follow-up.
时间窗: 0,1,3,6,12 Months
1.To asses the safety and performance of femoral neck system at 1 year follow-up
时间窗: 0,1,3,6,12 Months
2.To asses the safety and performance of dynamic hip system till 1 year follow-up
时间窗: 0,1,3,6,12 Months
次要结局
- 1.Complications [Time Frame: baseline, at 1, 3, 6, 12 months postoperatively].(2.Adverse Events)