NCT00699309已完成不适用
A Prospective, Non-controlled, Clinical Investigation of the Taperloc® Microplasty™ Hip System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- Harris Hip Score
研究概览
简要总结
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Taperloc® Microplasty™ Hip System.
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
- •Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- •Rheumatoid arthritis.
- •Correction of functional deformity.
- •Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- •Revision of previously failed femoral head resurfacing component
排除标准
- •Absolute contraindications include:
- •infection,
- •sepsis, and
- •osteomyelitis.
- •Relative contraindications include:
- •uncooperative patient or patient with neurologic disorders who are 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, or neuromuscular disease.
结局指标
主要结局
Harris Hip Score
时间窗: 5 years
次要结局
- Incidence of revision or removals(5 Years)
研究者
研究点 (4)
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