Clinical Study With the RM Pressfit Vitamys Cup in Combination With a Mathys Stem
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 675
- 主要终点
- Harris Hip Score (modified after Haddad et al, 1990)
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 RM Pressfit vitamys cup. The data will be used for an ongoing evaluation of the product safety and performance.
详细描述
Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the RM Pressfit vitamys cup. In total 675 participants in 9 clinics are included in this international multicenter study.
The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery.
The following parameters will be collected during the regular clinical and radiological follow-up: Harris Hip Score, radiographic evaluation and detection of adverse events.
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 95 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
- •Age at inclusion: Between 18 and 95 years old
- •Willing to participate in the follow-up
排除标准
- •Missing Informed consent form
- •Known or suspected non-compliance (e.g. drug or alcohol abuse)
- •Enrollment of the investigator, his/her family, employees and other dependent persons
- •Patient younger than 18 years old
- •Revision surgery
- •Presence of sepsis or malignant tumors
- •Pregnancy
结局指标
主要结局
Harris Hip Score (modified after Haddad et al, 1990)
时间窗: 2 years
The primary endpoint of the study is the Harris Hip Score (HHS) 2 years after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
次要结局
- Radiographic evaluation(6-12 weeks - 10 years)
- Adverse Events(6-12 weeks - 10 years)