NCT02127619已完成不适用
Prospective Study of Total Knee Replacement With the ROCC Knee
Bercovy, Michel, M.D.2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2001年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- locomotor function with the Knee society score
研究概览
简要总结
The purpose of this study was to assess the results of a Total Knee prosthesis specifically intended to enhance functional performance , especially in terms of physical and sports activity.
详细描述
Clinical and radiographic results , complications, early post-operative and late functional outcome and survivorship were studied in a continuous prospective series of 500 patients ( 602 knees) managed using the ROCC knee ( BIOMET INC - Warsaw- IND, USA).
A minimum follow-up of 5 years was required.
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
- 42 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients receiving a total knee
排除标准
- •patients with severe psychiatric, neurologic, cardiologic or locomotor pathology occuring after the total knee replacement
结局指标
主要结局
locomotor function with the Knee society score
时间窗: at a minimum of 5 years after surgery
次要结局
- clinical status with the Oxford knee score(at last follow-up examination, with minimum of 5 years after surgery)
- WOMAC ARTHRITIS INDEX(at last follow-up examination, with minimum of 5 years after surgery)
- physical and sports activities with the UCLA activity score(at last follow-up examination, with minimum of 5 years after surgery)
- clinical status with the Oxford Knee Score(before surgery)
研究者
Dr Bercovy
Orthopedic Surgeon
Bercovy, Michel, M.D.
研究点 (2)
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