Prospective Post Market Clinical Follow-up Study of the Avenir® Cemented Hip Stem
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
研究概览
简要总结
The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.
详细描述
This is a multicenter, prospective, non-controlled post-market clinical follow-up study to fulfill the post market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2.
The objectives of this study are to confirm the safety and performance of the Avenir Cemented Hip Stem when used in primary total hip arthroplasty at 6 weeks to 6 months, 1, 2, 3, 5, 7 and 10 years post-operatively.
The Avenir Cemented Hip Stem is a straight double-tapered stem offering 9 standard and 9 lateralized versions, the same as the uncemented version, the Avenir-Mueller Stem.
Safety will be evaluated by monitoring the frequency and incidence of adverse events and through radiographic review.
Performance will be based on the implant survival, overall pain and functional performances, subject quality-of-life and radiographic parameters of study subjects who received the Avenir® Cemented Hip stem.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient is 18 years of age minimum.
- •Patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history.
- •Patient is willing and able to cooperate in the required post-operative therapy.
- •Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
排除标准
- •Patient is unwilling or unable to give consent, or to comply with the follow-up program.
- •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., stainless steel).
- •Local bone tumors and/or cysts.
- •Pregnancy
- •Skeletal immaturity
- •Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, a known drug abuser or alcoholic or anyone who cannot understand what is required of them.
- •Patients with plans to relocate during the study follow-up period.
- •For patients biologically younger than 60 years with joint disease, a different reconstruction operation (e.g., osteotomy) or arthrodesis may be indicated.
结局指标
主要结局
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
时间窗: 10 years
次要结局
- Number of patient with adverse events related to the implant will be reported(10 years)
- The patient's quality-of-life will be determined by the EQ-5D score(10 years)
- Abnormalities determined on X-rays in the bone region surrounding the implant will be reported(10 years)
- The results of the hip surgery will be determined by the Harris Hip Score(10 years)