Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Implant Survivorship at 10 years follow-up (Kaplan Meier)
研究概览
简要总结
The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.
详细描述
The safety of this device will be assessed by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The performance will be evaluated by assessment of reported clinical outcome measures (PROMs) as well as radiographic outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 18 years of age or older.
- •Patient must be willing and able to follow directions.
- •Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem
排除标准
- •Off-label use.
- •Patient is a prisoner.
- •Patient is a current alcohol or drug abuser.
- •Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
- •Patient is unwilling to sign informed consent.
- •Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
研究组 & 干预措施
Treatment Group
The study population will comprise a consecutive cohort of 59 cases (males and females), implanted with the Comprehensive Primary Revision Stem.
干预措施: Comprehensive Primary Revision Stems (Device)
结局指标
主要结局
Implant Survivorship at 10 years follow-up (Kaplan Meier)
时间窗: 10 years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Frequency and Incidence of Adverse Events (Safety)
时间窗: 10 years
Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
次要结局
- Device Performance and Benefits evaluated through the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure.(10 years)