NCT00754416终止不适用
A Prospective, Multicentre Study Evaluating the Clinical Performance of the S.E.S Shoulder Prosthesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Constance and oxford Scores
研究概览
简要总结
This observational study intends to collect efficacy and safety data on S.E.S shoulder system
详细描述
The S.E.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.
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
- •A pre-operative level of pain and function the same as for conventional joint replacement
- •A likelihood of obtaining relief of pain and improved function
- •Full skeletal maturity
- •Ability to follow instructions
- •Good general health for age
- •Willing to return for follow-up evaluations
排除标准
- •Glenohumeral joint infection, osteomyelitis
- •Neuro-muscular complications
- •Inability to co-operate with and complete the study
结局指标
主要结局
Constance and oxford Scores
时间窗: 6m, 1yr, 2yr, 3yr, 4yr and 5 yr
次要结局
- Complication(Any time)
- Patient Satisfaction(6m,1yr,2yr,3yr,4yr and 5yr)
研究者
研究点 (12)
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