A Prospective, Non-randomized, Consecutive Series, Multicenter, Observational Trial to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 175
- 试验地点
- 5
- 主要终点
- Revision for any reason
研究概览
简要总结
Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.
详细描述
Multicenter, prospective, observational study to collect relevant clinical data from 167 subjects implanted with the Journey II BCS Knee System. Data from eligible subjects, who have provided written informed consent for the collection of their coded data will be recorded from the patient's medical file on specially designed case report forms (CRF's).
Total study duration for participants will be 10 years with follow-up visits planned at 3 months, 1 year, 2 years, 5 years and 10 years post-surgery. An interim analysis describing the clinical outcome is planned after 5 years.
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 75 Years（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
- •age > 75 years
- •conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- •subject has inadequate bone stock to support the device
结局指标
主要结局
Revision for any reason
时间窗: 10Years
The goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate of 94.3% (AOA annual report 201121) at 10 years. "Success" is defined as 10 year survival of the study device without revision for any reason.
次要结局
- complication rate (adverse events and revisions)(discharge, 3month, 1yr, 2yr, 5yr, 10yr)
- 2011 Knee Society Score(pre-op, 3month, 1yr, 2yr, 5yr, 10yr)
- radiographic evaluation(pre-op, discharge, 3month, 1yr, 5yr, 10yr)
- EQ-5D questionnaire(pre-op, 3month, 1yr, 2yr, 5yr, 10yr)
- Knee Pain Evaluation Form questionnaire(3month, 1yr, 2yr)