Long-Term Multicenter Evaluation of the E1® Tibial Bearing
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Survivorship, as determined by the implant remaining within the patient.
研究概览
简要总结
This study has been designed to document the long-term outcome of the E1® Tibial Bearings used with the Vanguard® Knee System in 500 patients receiving total knee arthroplasty. All patients will receive the E1® Tibial Bearing in a Vanguard® knee replacement. Radiographic analysis and patient reported outcomes will be used as follow-up measures to track wear, mechanical performance, and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •20 to 75 years of age
- •Subjects requiring total knee replacement
- •Subjects with the diagnosis of osteoarthritis, or traumatic arthritis
- •Subjects who demonstrate the ability to return to Massachusetts General Hospital for follow-up for the next 10 years
排除标准
- •Subjects with osteoporosis, osteomalacia, or neuromuscular disease
- •Incomplete or insufficient soft tissue around the knee
- •Subjects with a limited life span
- •Subjects who have difficulty comprehending the study protocol for any reason
- •Subjects with disorders which may impair bone formation
- •Subjects whose bony structure deviates substantially from the general norm
- •Female subjects that are, or may become, pregnant while participating in this study
研究组 & 干预措施
E1 Tibial bearing
All patients undergoing primary total knee replacement surgery will receive a tibial bearing made of E1 polyethylene, which is the material being monitored in this study.
干预措施: Total knee arthroplasty (Procedure)
结局指标
主要结局
Survivorship, as determined by the implant remaining within the patient.
时间窗: 10 years
次要结局
未报告次要终点
研究者
Charles R. Bragdon
Associate Director, Clinical Studies
Massachusetts General Hospital