NCT00765037已完成不适用
Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Survivorship of the Encore Reverse Shoulder Prosthesis
研究概览
简要总结
The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.
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
- •The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
- •The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
- •The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
排除标准
- •Infection or sepsis
- •Insufficient bone quality which may affect the stability of the implant, as determined by the physician
- •Muscular, neurological, or vascular deficiencies, which compromise the affected extremity
- •Alcoholism or other addictions
- •Materials (metals, etc) sensitivity
- •Loss of ligamentous structures
- •High levels of physical activity
- •Non-functional deltoid muscle
结局指标
主要结局
Survivorship of the Encore Reverse Shoulder Prosthesis
时间窗: 1 year
Number of subjects who completed all study visits through the 1 year visit.
次要结局
未报告次要终点
研究者
研究点 (1)
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