Multicenter Clinical Observation PROMOS®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 主要终点
- Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components
研究概览
简要总结
Overall study design:
This study is a prospective, multicenter, postmarket clinical observation to validate the PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder arthroplasty in terms of radiographic and clinical performance as well as long-term survivorship over 10 years.
详细描述
Primary objective:
Radiological and clinical loosening rates of the glenoid and humeral components must be comparable or below the rates of other well documented state-of-the-art shoulder systems with cemented glenoid components. Complications occurring intra- or postoperatively will be assessed and sub-classified in their relation to the implant.
At the end of the observation, a long-term survival rate will be calculated according to Kaplan-Meier with revision due to aseptic loosening as the end-point.
Secondary objectives:
The Constant Murley score and the ASES clinical evaluation are used for documenting the improvement in pain, function and range of motion. For the patient's subjective view of improvement in function a patient self-assessment form is used.
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
- •patient has no general medical contraindication to surgery
- •informed consent to participate in the observation signed by the patient
- •routine radiographic assessment is possible
- •patient is likely to comply with study follow-up requirements
- •primary total- or hemi-shoulder-arthroplasty to the affected side, unilateral or bilateral
排除标准
- •acute shoulder trauma
- •tumor / malignoma
- •avascular necrosis
- •late stage rotator cuff disease
- •Charcot joint disease or other severe neurosensory deficits
- •high comorbidity
- •previously failed shoulder arthroplasty
- •fracture sequelae of proximal humerus
- •hypersensitivity to the implant materials used
- •addictive disorders such as alcohol or drug abuse
- •severe spinal disorders
- •bacterial infections
结局指标
主要结局
Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components
时间窗: up to 10 years
The long-term survival rate of the Promos™ Standard shoulder system was calculated with revision due to aseptic loosening as endpoint using a Kaplan-Meier Analysis.
次要结局
- Constant Murley Score(10 Years)
- ASES Shoulder Score Index(10Years)