NCT00733915已完成4 期
A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS) Complete Mobile-bearing Total Knee System.
DePuy International2 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2002年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- To demonstrate the surgical performance of the LCS Complete mobile-bearing total knee system and instrumentation using radiographic and intra-operative assessment
研究概览
简要总结
The main objective of this study is to evaluate how the LCS Complete mobile-bearing total knee system and surgical instrumentation performs.
详细描述
The secondary objective of this investigation is to evaluate the long-term survivorship and performance of the LCS Complete mobile-bearing total knee system and surgical instrumentation using the American Knee Society Score (AKS) the Oxford Knee Score (OKS), SF-12 and survivorship analysis.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects.
- •Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained
- •Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •Subjects who present with idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with a mobile bearing knee system (LCS Complete).
- •Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
排除标准
- •Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- •Subjects with a known history of poor compliance to medical treatment.
- •Women who are pregnant.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- •Subjects involved in Medical-Legal claims.
- •Subjects who have participated in a clinical study with an investigational product in the last month.
- •Subjects who are currently involved in any injury litigation claims.
- •Revision of an existing knee implant.
结局指标
主要结局
To demonstrate the surgical performance of the LCS Complete mobile-bearing total knee system and instrumentation using radiographic and intra-operative assessment
时间窗: 10 years
次要结局
- To demonstrate the survivorship and performance of the LCS Complete mobile-bearing total knee system using the American Knee Society clinical and radiographic assessment, Oxford Knee Score, SF12 and survivorship analysis.(Pre surgery, surgery, 3 month, 1, 3, 5 and 10 years)
研究者
研究点 (2)
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