NCT01873651撤回4 期
The Reverse Delta III Total Shoulder Prosthesis - Longerm Results in 98 Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Constant Murley Score
研究概览
简要总结
The aim of the study is to describe the results after > 10 years due to a prosthesis implant.
详细描述
The aim of the study is to measure the gain of the benefit in function an painreduction which the patient yields with this type of prosthesis in a longterm (> 10 years )outcome. Additionally the long-term results will be compared with the mid-term results and the literature. Furthermore the complications since the mid-term measurement time point will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •implantation of a Delta III - prothesis
- •timeframe (Oct 1998 - Dec 2002)
- •delta-pectoral approach
- •written informed consent
排除标准
- •Implantation because of a revision
- •Complaints, which make it difficult to follow instructions or even prevent
结局指标
主要结局
Constant Murley Score
时间窗: 10 years
次要结局
- cASES(10 years)
- pASES(10 years)
- SF-36(10 years)
- DASH-Questionannaire(10 years)
- SPADI(10 years)
- x-ray (Sperling Classification)(10 years)
- x-ray (Sirveaux Classification)(10 years)
- Description of the glenoid(10 years)
- Description of the stem(10 years)
研究者
Matthias Flury
Principal Investigator (Department of Upper Extremity)
Schulthess Klinik
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