NCT00487565已完成不适用
LCS® PS: A Prospective, Multi-center Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Knee Active Flexion
研究概览
简要总结
Prospective, multi-center clinical study to evaluate the clinical outcomes of the posterior stabilized design of the LCS® Complete Mobile-bearing Total Knee System
详细描述
Prospective, multi-center study to evaluate the clinical outcome of posterior stabilized design of LCS® Complete Mobile-Bearing Total Knee System. No comparison group. 12 month enrollment, 12 month post-operative evaluation. Follow-up intervals: Pre-op, 3 month, 6 month, and 12 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of osteoarthritis, rheumatoid , post-traumatic, inflammatory, juvenile arthritis.
- •Skeletally mature, sufficient bone stock to seat and support prosthesis
- •Willing/able return for follow-up.
- •Subject is willing and able to provide informed patient consent for participation in the study
排除标准
- •History of recent/active joint sepsis, charcot neuropathy, psycho-social disorders, prior knee arthroplasty on affected site, metabolic disorders of calcified tissue
- •Communicable diseases that may limit follow-up
- •Medical-legal or workers compensation claims.
研究组 & 干预措施
LCS Complete Posterior Stabilized knee implant
Other
Total knee arthroplasty with a posterior stabilized implant
干预措施: Total knee arthroplasty (Device)
结局指标
主要结局
Knee Active Flexion
时间窗: 12 month
Active flexion is measured by how much a patient can bend their knee on their own, without assistance.
次要结局
未报告次要终点
研究者
研究点 (3)
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