NCT00699257终止不适用
A Prospective, Non-controlled, Clinical Investigation of the Oxford® Partial Knee System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 85
- 主要终点
- Knee Society Score
研究概览
简要总结
The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. The implant is intended to be implanted with bone cement.
排除标准
- •Infection
- •Use in the lateral compartment of the knee
- •Rheumatoid arthritis or other forms of inflammatory joint disease
- •Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
- •Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
- •Disease or damage to the lateral compartment of the knee
- •Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- •Osteoporosis
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Distant foci of infections which may spread to the implant site
- •Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy, neuromuscular disease
- •Incomplete or deficient soft tissue surrounding the knee
- •Charcot's disease
- •A fixed varus deformity (not passively correctable) of greater than 15 degrees
- •A flexion deformity greater than 15 degrees
结局指标
主要结局
Knee Society Score
时间窗: 6 weeks, 3 months, 1 year, 3 years, 5 years
Oxford-12 Self Assessment Form
时间窗: 6 weeks, 3 months, 1 year, 3 years, 5 years
次要结局
- Incidence of revisions and removals(Any time)
研究者
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