Clinical and Functional Outcome of the Gemini SL Fixed Bearing at Midterm Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 254
- 试验地点
- 3
- 主要终点
- Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point
研究概览
简要总结
This is a retrospective, multicenter case series with a prospective follow-up to confirm the safety and performance of the Gemini SL Fixed Bearing knee prosthesis in midterm follow-up under routine conditions. Primary outcome of the study is the 5-year survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point.
详细描述
Sufficient data (e.g. biomechanical tests, biocompatibility, vigilance data and results of risk management, clinical data of comparable devices) are available for assessing the safety and performance of the Gemini SL knee prosthesis system. Unfortunately, no data are available for the Gemini SL Fixed Bearing knee prosthesis. As one part of the post market surveillance (PMS) system of the sponsor, the clinical outcome of the Gemini SL Fixed Bearing knee prosthesis in the midterm follow-up shall be evaluated. Therefore patients who received a Gemini Sl Fixed bearing knee prosthesis 3 years ago are invited to participate in follow-up examinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Implantation of a Gemini SL Fixed Bearing knee prostheses 3 years ago
- •Age between 18 and 75 years at the time of implantation
排除标准
- •Body Mass Index (BMI) > 40 kg/m² at the time of implantation
- •Comorbidities and known medical circumstances which would affect the clinical functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation
结局指标
主要结局
Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point
时间窗: 5 years
Revision for any reason is defined as removal, replacement or adding of any implant components, except subsequent implantation or replacement of the patella surface or the polyethylene plateau.
次要结局
- Complication rates(3 and 5 years)
- Subsequent surgical interventions(3 and 5 years)
- Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point(3 years)
- Evaluation of the functional and clinical outcome of the Gemini SL Fixed Bearing knee prosthesis measured by the Knee Society Score(3 and 5 year)