A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Forgotten Joint Score
研究概览
简要总结
The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.
详细描述
This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study with 140 subjects with 2 years follow-up.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Forgotten Joint Score
时间窗: Preoperative, 1 year, and 2 years visits
12 questions and measure the ability of the patient to forget their operated knee after the surgery.
The Self-Administered Patient Satisfaction Scale
时间窗: Preoperative, 1 year, and 2 years visits
Patients' overall satisfaction with surgery, the extent of pain relief, the ability to perform home or yard work, and the ability to perform recreational activities.
次要结局
- Oxford Knee Score (OKS)(Preoperative, 1 year, and 2 years visits)
- EQ-5D-5L(Preoperative, 1 year, and 2 years visits)
- Knee Society clinical rating system (KSS) Objective Knee Indicators(Preoperative, 1 year, and 2 years visits)
- Single Leg Stance test(Preoperative, 1 year, and 2 years visits)
- Time Up & Go tests(Preoperative, 1 year, and 2 years visits)