Observational and Prospective Multicenter Study to Evaluate the Long-term (10 Years) Performance and Safety (10 Years) of ATF Implants and Lapé Médical Devices Implanted During Total Hip Arthroplasty or Hemiarthroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,500
- 试验地点
- 13
- 主要终点
- Long-term survival rate
研究概览
简要总结
Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
详细描述
Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
The post-market clinical follow-up study to be conducted by ATF Implants following this plan aims to collect data from the follow-up of patients before and after hip replacement surgery with implants manufactured by ATF Implants and Lapé médical. In current practice, the surgeon-investigator evaluates the patient pre- and post-operatively according to predefined criteria used in orthopedic surgery and more particularly in hp replacement surgery. Complications and adverse effects observed are also recorded.
The main objective is to gather clinical evidence to evaluate the survival rate of ATP Implants and Lapé médical hip prostheses over the long-term, namely 10 years.
The secondary objectives are to evaluate the performance and safety of the prostheses over the same period (i.e. 10 years), as well as to obtain feedback on the performance /intended use and safety of the surgical instruments required for implant placement.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female indicated for hip replacement surgery with hip prosthesis manufactured by ATF Implants and/or Lapé médical;
- •There are different indications for hip replacement surgery. The main ones are listed below:
- •Dysplasia
- •Primary Coxarthrosis
- •Secondary Coxarthrosis
- •Perthes disease
- •Epiphysiolysis
- •Ankylosing spondylitis
- •Trochanteric bursitis
- •Arthritis
- •Degenerative arthritis
- •Post-traumatic arthritis
- •Rheumatoid arthritis
- •Femoral neck fracture
- •Osteonecrosis
- •Depending on the specificities of the devices (size, absence/presence of a coating, material), indications may vary. This information can be found in the instruction for use. It is the surgeon's responsibility to select the most appropriate prosthesis for a given patient according to the patient's medical records and the instruction for use in force at the time of the procedure accompanying the medical device.
排除标准
- •There are various contraindications for hip arthroplasty. The main ones are listed below:
- •An acute or chronic, local or systemic infection
- •Severe muscular, neurological or vascular deficiency compromising the affected extremity
- •A bone defect or insufficient bone quality that may compromise the stability of the implant
- •Any concomitant disease (dysplastic coxarthrosis with extreme coxa valga, short neck and severe varus) that may affect the function of the implant
- •Sensitivity to the material (allergy) Depending on the specificities of the devices (size, absence/presence of a coating, material), contraindications may vary. This information can be found in the instruction for use of the devices.
结局指标
主要结局
Long-term survival rate
时间窗: 10 years
Long-term survival rate of the prostheses (10 years) with failure defined as revision surgery when considering all causes using Kaplan-Meier method.
次要结局
- hip joint function(before and after surgery (6 month, 2 years, 5 years, 7 years, 10 years))