Patient Benefit From the New Modular Shoulder Prosthesis PROMOS - a Multicentre Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Primary outcome measures: Patient benefit will be measured with the SPADI and Constant Murley score at the joint level, with the QuickDASH for the upper extremity and the SF-36 mental score as a generic tool.
研究概览
简要总结
Overall study design:
This study is a prospective, non-randomized, multicenter postmarket clinical follow-up study with two study arms using the two shoulder prosthesis PROMOS™ STANDARD (group A) and PROMOS REVERSE™ (group B). The study will collect efficacy and safety data over 10 years.
详细描述
Primary objective of the study:
The primary objective is to quantify patient benefit after primary total shoulder arthroplasty with the modular PROMOS™ shoulder system in a multicenter cohort study (real world approach). Patient benefit will be quantified using objective and validated subjective measures of function, activities of daily living (ADL) and quality of life (QoL).
Secondary objectives:
- Rate of implant related findings like radiological loosening of the glenoid and complications like intraoperative stem fissures
- Prosthesis survival at common time points, e.g. 5 and 10 years
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
- •Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty
- •Massive rotator cuff rupture
- •Willing an able to give written informed consent to participate in the study including follow-ups
排除标准
- •Previous ipsilateral shoulder arthroplasty (group A and B)
- •Late stage rotator cuff disease (only group A)
- •Acute shoulder trauma (group A and B)
- •General medical contraindication to surgery (group A and B)
- •Legal incompetence (group A and B)
- •Tumour / malignoma (group A and B)
- •Recent history of substance abuse (group A and B)
- •Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) (group A and B)
- •Known hypersensitivity to the materials used (group A and B)
- •Bacterial infection at the time point of operation (group A and B)
结局指标
主要结局
Primary outcome measures: Patient benefit will be measured with the SPADI and Constant Murley score at the joint level, with the QuickDASH for the upper extremity and the SF-36 mental score as a generic tool.
时间窗: Preop / 6M / 1Y / 2Y / 5Y / 10Y
次要结局
- Active and passive ROM and strength / Rate of implant related complications / Rate of implant related findings like radiological loosening of the glenoid / Prosthesis survival at common time points, e.g. 5 and 10 years(Preop / 6M / 1Y / 2Y / 5Y / 10Y)