NCT00578851已完成不适用
Post Approval Study of the C2a-Taper™ Acetabular System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Harris Hip Score, Radiographic Evaluation
研究概览
简要总结
The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.
详细描述
Study Design:
Phase 1
Sites will collect the following types of data:
Clinical-Total Harris Hip Score, Radiographic Evaluation- measurements on acetabular and femoral components Survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) Safety- All other adverse events
Follow-up Visit schedule
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
- •Skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis
排除标准
- •Patients with: Osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, vascular insufficiency, muscular atrophy, and neuromuscular disease
结局指标
主要结局
Harris Hip Score, Radiographic Evaluation
时间窗: 5 years
次要结局
- Survivorship(10 years)
研究者
研究点 (2)
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