Comprehensive Segmental Revision System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 6
- 主要终点
- Implant survivorship assessed according to the implant revisions
研究概览
简要总结
Clinical Data evaluation to document the performance and clinical outcomes of the Comprehensive Segmental Revision System.
详细描述
The Purpose of this multi centre clinical data evaluation is to document the performance and clinical outcomes of the Comprehensive Segmental revision System. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as part of Zimmer Biomets Post Market Surveillance.
The Comprehensive Segmental Revision System consists of a proximal humeral replacement system (shoulder prosthesis), a distal humeral replacement system (elbow prosthesis) and of a total humeral replacement system (shoulder and elbow prosthesis connected by a humeral coupler).
Patient outcomes will be measured by using measurement tools that have been extensively used and referred to in the literature. Specifically, the quickDASH will be used for all cases enrolled in the study. In addition, the Constant and Murley Score may be used for shoulder applications, the Liverpool Elbow Score may be used for elbow applications and the MSTS Score may be used for tumor cases.
The study population will be compromised of males and females that are eligible according to the inclusion/exclusion criteria. The study will last for at least ten (10) years from the time of surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non Inflammatory Degenerative joint disease, including osteoarthritis, and avascular necrosis
- •Rheumatoid arthritis
- •Revision where other devices or treatments have failed
- •Correction of functional deformity
- •Oncology applications including bone loss due to tumour resection
排除标准
- •Sepsis ( active)
- •Infection ( active)
- •Osteomyelitis (active)
结局指标
主要结局
Implant survivorship assessed according to the implant revisions
时间窗: 10 years
Implant survivorship assessed counting the number of implant revisions
次要结局
- Clinical patient outcome measure: Constant-Murley Score(Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative)
- Clinical patient outcome measure: Musculoskeletal Tumour Society Scoring System (MSTS)(6 months, 1 year, 3 years and 5 years post-operative)
- Clinical patient outcome measure: Liverpool Elbow Score(Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative)
- Clinical patient outcome measure: QuickDASH(Pre-operative and at 6 months, 1 year, 3 years and 5 years post-operative)
- Safety is assessed according to the number of complications(10 years)