Post Market Clinical Follow-Up Study of the Zimmer Stafit Acetabular System. A Multicenter, Prospective, Non-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 166
- 主要终点
- Dislocation Rate
研究概览
简要总结
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.
详细描述
The objective of this study is to obtain implant survival and outcome data on the Stafit Acetabular System by analysis of standard scoring systems, radiographs, and adverse event records.
Data will be used to monitor pain, mobility, dislocation rate and implant survival, and to confirm the long-term safety and performance of the Stafit Acetabular System in primary total hip arthroplasty.
The study design is a multi-center, prospective, non-controlled, consecutive cohort post market clinical follow-up study, involving orthopedic surgeons skilled in total hip arthroplasty procedures and experienced with the Stafit Acetabular System.
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
- •Males and females
- •Patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty.
- •18 years minimum
- •Patients able to participate in a follow-up program based upon physical examination and medical history
- •Patients who have provided written informed consent by signing the Patient Informed Consent Form.
排除标准
- •Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program
- •Known pregnancy
- •Revision hip arthroplasty
结局指标
主要结局
Dislocation Rate
时间窗: 2 years
Assessed by counting the number of implant dislocations
Implant Survival
时间窗: 3 years postoperatively, due to early study termination
Represents the implants that survived by counting the number of implants revised.
次要结局
- Evaluation of Pain and Functional Performance Determined by the Harris Hip Score(3 years postoperatively, due to early study termination)
- Confirmation of Safety Based on Complications(3 years postoperatively, due to early study termination)