NCT00764842终止不适用
Post-Market Study: The Efficacy of the CLP® Hip
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- The survivorship and efficacy of the Encore CLP® Hip stem
研究概览
简要总结
The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip stem in a group of no more than 200 patients from whom data has already been collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 must be 18 years of age or older.
- •Noninflammatory degenerative joint disease including
- •Osteoarthritis of the natural femoral head
- •Avascular necrosis of the natural femoral head
- •Rheumatoid arthritis
- •Correction of functional deformities
- •Femoral fracture
- •Patients must be able and willing to complete all study-related visits.
排除标准
- •Anyone who is under 18 years of age
- •Infection or sepsis
- •Insufficient bone quality which may affect the stability of the implant
- •Muscular, neurological or vascular deficiencies, which compromise the affected extremity
- •Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock, poor skin coverage around hip joint which would make the procedure unjustifiable
- •Osteomyelitis
- •Rapid joint destruction or bone absorption apparent on roentgenogram
- •Pathological conditions of the acetabulum which would prevent achieving proper range of motion, appropriate head stability, and/or a well-seated and supported smooth articulation of the head within the acetabulum
- •Alcoholism or other addictions
- •Materials sensitivity
- •Loss of ligamentous structures
- •High levels of physical activity (e.g., competitive sports, heavy physical labor)
结局指标
主要结局
The survivorship and efficacy of the Encore CLP® Hip stem
时间窗: 2 year
次要结局
未报告次要终点
研究者
研究点 (1)
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