Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete™ Femoral Stem (Implants and Instrumentation)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 275
- 试验地点
- 18
- 主要终点
- Survival of the study device; whether or not it is still implanted in the subject
研究概览
简要总结
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.
详细描述
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete™ femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty:
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on the removal or intended removal of the "study device and determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 20 years old or older and skeletally mature.
- •Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
- •Failed previous hip surgery including
- •Joint reconstruction (osteotomy)
- •Arthrodesis
- •Hemi-arthroplasty or total hip replacement (THR)
- •Acute traumatic fracture of the femoral head or neck;
- •Avascular necrosis of the femoral head.
- •Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
排除标准
- •Acute, chronic, local, or systemic infections;
- •Severe muscular, neural, or vascular diseases that endanger the limbs involved;
- •Lack of bony structures proximal or distal to the joint, so that good Inclusion criteria
- •Patient is at least 20 years old or older and skeletally mature.
- •Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
- •Failed previous hip surgery including
- •Joint reconstruction (osteotomy)
- •Arthrodesis
- •Hemi-arthroplasty or total hip replacement (THR)
- •Acute traumatic fracture of the femoral head or neck;
- •Avascular necrosis of the femoral head.
- •Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
- •Exclusion criteria
- •Acute, chronic, local, or systemic infections;
- •Severe muscular, neural, or vascular diseases that endanger the limbs involved;
- •Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible;
- •Total or partial absence of the muscular or ligamentous apparatus;
- •Any concomitant diseases that can jeopardize the functioning and the success of the implant;
- •Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel, etc.);
- •Local bone tumors and/or cysts;
- •Pregnancy;
- •Skeletal immaturity.
- •Patients unwilling or unable to give consent, or to comply with the follow-up program;
- •Patients who have any condition that would - in the judgement of the Investigator - place him/her at undue risk or
- •interfere with the study;
- •Any vulnerable subject:
- •a prisoner
- •mentally incompetent or unable to understand what participation in the study entails
- •a known alcohol or drug abuser
- •anticipated to be non-compliant
- •Patients with plans to relocate during the study follow-up period;
- •Individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate;
研究组 & 干预措施
Avenir Complete Femoral Stem
All enrolled subjects receive the study implant
干预措施: Avenir Complete Femoral Stem (Device)
结局指标
主要结局
Survival of the study device; whether or not it is still implanted in the subject
时间窗: 10 years
Survival is classified as removal of the study device for any reason
次要结局
- Radiographic analysis(10 years)
- Oxford Hip Score(10 years)
- Patient Quality of Life(10 years)
- Incidence of treatment-emergent Adverse Events (safety)(10 years)
- Harris Hip Score(3 years)