NCT00699270撤回不适用
A Prospective, Non-Controlled, Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- X-rays
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 Biomet Humeral Stems
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
- •Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- •Rheumatoid Arthritis
- •Correction of functional deformity
排除标准
- •Absolute contraindications:
- •Infection, Sepsis, and Osteomyelitis
- •Relative contraindications:
- •Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
- •Osteoporosis
- •Metabolic disorders which may impair bone function
- •Osteomalacia
- •Distant foci of infections which may spread to the implant site
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
结局指标
主要结局
X-rays
时间窗: 3 month, 1 year, 3 years, 5 years
UCLA End Result Score
时间窗: 3 months, 6 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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