A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Implant survival at 2 years
研究概览
简要总结
A post market, non-randomized, multi-center, open-label,clinical study using survivorship to study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when used for total shoulder arthroplasty.
详细描述
Observational, multi-center, post-market study to provide data on the performance and safety of the TITAN™ Total Shoulder System. The study will enroll patients that underwent total shoulder arthroplasty with the TITAN™ Total Shoulder System per standard of care less than 5 years ago. Available retrospective data up to the 2-year time point will be collected, per the study protocol, from medical record reviews. Prospective observational data will be collected from the time of patient enrollment during the following postoperative clinical visits: 1 year, 2 years, 5 years and 10 years post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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
- •Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
- •The first generation TITAN Total Shoulder System is still intact and the subject has not received any revision surgeries involving the TITAN Total Shoulder System.
- •Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.
排除标准
- •Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study such as mental illness, or drug or alcohol abuse.
- •Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
结局指标
主要结局
Implant survival at 2 years
时间窗: 2 years
Implant survivorship is defined as absence of device removal or revision of one or more of the implant component(s).
次要结局
- Implant survival .(5 and 10 years)
- Radiographic assessment(2, 5, and 10 years)
- Relative change in Quality Of Life (EQ-5D) compared to baseline(2, 5, and 10 years)
- Relative change of American Shoulder and Elbow Surgeon Score (ASES) compared to baseline(2, 5, and 10 years)
- Relative change of Range of Motion (ROM) compared to baseline(2, 5, and 10 years)
- Relative change in Quality Of Life (SF-12V1) compared to baseline(2, 5, and 10 years)
- Relative change of PENN Pain and Function Score (PENN) compared to baseline(2, 5, and 10 years)