NCT05926622招募中不适用
Clinical and Radiological Outcomes of Medacta Shoulder System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Survival Rate
研究概览
简要总结
This is a post-marketing surveillance on Medacta Shoulder 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
- •Patients older than 18 years
- •Patient with one of the following diagnosis:
- •Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty
排除标准
- •Patients with malignant diseases (at the time of surgery)
- •Patients with proven or suspect infections (at the time of surgery)
- •Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery)
- •Patients with known incompatibility or allergy to products materials (at the time of surgery)
结局指标
主要结局
Survival Rate
时间窗: 10 years
Kaplan Meier method
次要结局
- Adverse events(up to 10 years)
- Clinical outcome evaluating Constant & Murley Score(1, 2, 5 and 10 years)
- Radiographic performance of the implants evaluating presence of radiolucencies(3 months, 1, 2, 5 and 10 years)
- Functional outcome evaluating Oxford Shoulder Score(1, 2, 5 and 10 years)
- Patient evaluation quality of life(1, 2, 5 and 10 years)
研究者
研究点 (1)
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