NCT02412397Unknown不适用
DePuy Global Unite Shoulder System
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Implant Survivorship
研究概览
简要总结
To collect medium to long-term survivorship implant outcomes on the DePuy Global Unite Shoulder System
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patient greater than 18 years of age and skeletally mature
- •Patient qualifies for primary or revision total or reverse shoulder arthroplasty based on diagnosis of investigator of osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, un-united humeral head fractures, irreducible 3- and 4- part proximal humeral fracture, avascular necrosis, or gross rotator cuff deficiency.
- •Patient is willing and able to provide written informed consent and to complete scheduled follow up visits/evaluations/questionnaires
排除标准
- •Patient has one of the following compromise the affected limb; a significant injury to the upper brachial plexus, paralysis of the axillary nerve, or a neuromuscular disease compromising the affected limb
- •Patient has a known or suspected infection
- •Patient is known to be pregnant
- •Patient has a sensitivity or allergic reaction to one or more of the implanted materials
- •Patient is unwilling or unable to provide consent or comply with follow up visits
结局指标
主要结局
Implant Survivorship
时间窗: 10 years post-operative
次要结局
未报告次要终点
研究者
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