Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System - "U-Propel Study"
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Implant Survivorship
研究概览
简要总结
The purpose of this study is to evaluate both short and long term clinical performance and safety of the commercially available U2 Knee™ System.
详细描述
This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total knee arthroplasty (TKA) with the U2 Knee™ System. The study will enroll up to 200 subjects with scheduled pre-discharge, 6-week, 3- and 6-month and up to 5-year annual follow-up visits. Study outcomes will be analyzed and published when 1.) all enrolled and implanted subjects complete their 6-week follow up, 2.) all implanted subjects complete their 2-year follow up, 3.) at the conclusion of the study.
The study will follow GCP guidelines and will be registered on clinicaltrials.gov.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 18 and 75 years of age
- •Subject is indicated for a unilateral total knee arthroplasty (TKA) based on the approved labeling of the device
- •Subject has no history of previous prosthetic replacement device or orthopedic surgeries on the operative knee
- •Subject is willing and able to provide informed consent to participate in the study;
- •Subject is willing and able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits;
排除标准
- •Subjects will be excluded if, in the opinion of the Investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
结局指标
主要结局
Implant Survivorship
时间窗: 2 Years
Device Survivorship defined as no revision of removal of any parts of the system
次要结局
- Change in EQ-5D Over Time(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years)
- Change in EQ-5D VAS Over Time(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years)
- Radiographic Analysis(24 months, 5 years)
- Subject Satisfaction Survey(6 weeks, 3 months, 6 months, 12 months, 2 Years, 3 Years, 4 Years and 5 Years.)
- Change in KOOS, JR. Over Time(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years)
- Change in Knee Society Score (KSS) Over Time(Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months, 3 years, 4 years, 5 years)
- Operative characteristics(Operative)