NCT00578994已完成不适用
A Prospective, Non-randomized, Multicenter Study of the Oxford® Meniscal Unicompartmental Knee System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 6
- 主要终点
- Survivorship
研究概览
简要总结
The purpose of this study is to collect information on complications and survivorship of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.
详细描述
Study Objective
To provide a prospective 2-year post-operative evaluation of complications and 9-year long-term survivorship analysis of patients implanted with the Oxford™ Meniscal Unicompartmental Knee System at multiple sites in the United States.
Study Design
The study is designed as a prospective, multi-center, non-randomized post approval study. There are two phases to this study:
- A complications study where patients will be followed for at least 2 years to record all complications that may occur, and
- A survival study that will record at yearly intervals out to 9 years whether or not the device is still in place or if it has been removed for any reason.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with one of the following diagnoses in the medial compartment of the knee: Osteoarthritis, Avascular Necrosis
排除标准
- •Patients with Rheumatoid arthritis or other forms of inflammatory joint disease
- •Patients with infection, sepsis, and osteomyelitis
- •Patients with Osteoporosis, Paget's Disease, Charcot's disease, Osteomalacia, and Severe Osteoporosis
结局指标
主要结局
Survivorship
时间窗: Annually for 9 years post-op
Assessment of frequency of Revisions
次要结局
- Complications(2 Years)
研究者
研究点 (6)
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