A Post Market Clinical Follow-up Study With the aneXys Cup
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Cup migration after 2 years
研究概览
简要总结
The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the aneXys cup. The data will be used for an ongoing evaluation of the product safety and performance.
详细描述
Prospective observational multicenter case series providing short-term migration results and long-term post-market clinical data on the safety and performance of the aneXys cup. The study includes patients undergoing primary total hip arthroplasty. In total 100 patients in 3 clinics will be included. In each clinic 10-57 consecutive patients shall be included. In addition, to meet the regulatory requirements, a total of minimum 20 cases with screw fixation shall be included in the study.
Clinical and radiological follow-up (FU) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7 and 10 years. An additional FU at 3 years is planned to apply for an ODEP (Orthopaedic Data Evaluation Panel) rating.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent form (signed by participant and investigator)
- •Primary implantation
- •Suffer from primary or secondary osteoarthritis of the hip, femoral head and neck fractures or necrosis of the femoral head. In all cases a stable anchoring of the implant has to be possible.
- •Age at inclusion: between 18 and 75 years old
- •Willing to participate in the follow-up examinations
- •Complete recovery is expected
排除标准
- •Missing informed consent form (signed by participant and investigator)
- •Known or suspected non-compliance (e.g. drug or alcohol abuse)
- •Enrolment of the investigator, his/her family, employees and other dependent persons
- •Patients younger 18 years old
- •Revision surgery
- •Presence of sepsis or malignant tumours
- •ASA (American Society of Anesthesiologists) Classification >3
- •Pregnancy
研究组 & 干预措施
aneXys
cases with aneXys cup and Mathys hip stem
干预措施: aneXys (Device)
结局指标
主要结局
Cup migration after 2 years
时间窗: 2 years
The primary endpoint will be the radiographic evaluation of the acetabular cup migration based on performed EBRA measurements 2 years after surgery.
次要结局
- Visual analogue scale vor pain(10 years)
- The Western Ontario and McMaster Universities Osteoarthritis Index(10 years)
- Harris Hip Score(10 years)
- Visual analogue scale for satisfaction(10 years)