A Retrospective-Prospective Study of REDAPT™ Revision Femoral System Modular Stem
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- Modular stem revision
研究概览
简要总结
A Retrospective-Prospective Study of REDAPT Revision Femoral System Modular Stem is a post-market, retrospective-prospective, multi-center, single arm, consecutive series study design to provide data on the post market performance and safety of the study device. The study will collect retrospective data from medical records review and prospective data from observations data at 5 and 10 postoperatively clinical visits. There will also be a 7.5 year telephone follow up contact to assess for device status and adverse events.
详细描述
The primary purpose of this study is to demonstrate the REDAPT™ Revision Femoral System modular stem cumulative revision rate at 5 years.
The secondary purpose of this study is to provide 10 years of safety and performance data on the REDAPT™ Revision Femoral System modular stem in terms of Standard of Care Radiographic Assessment, Harris Hip Sore (if obtained prior to implant), adverse event assessment, whole blood metal ion level assessment for Cobalt and Chromium (only performed if subject if symptomatic with pain, swelling, and/or functional limitation related to the device and/ implant procedure as assessed by the Principal Investigator (PI), and Metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) or Computed Tomography (CT) will be obtained if metal ion levels of Cobalt and/or Chromium > 7parts per billion (ppb) 140 subjects have been enrolled in the study at 5 clinical study sites around the world. A Clinical Study Report (CSR) will be completed at years 5 and 10.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retrospective Limited Data Collection/Enrollment Phase:
- •Subject has undergone revision hip arthroplasty with the REDAPT™ Revision Femoral System modular stem with implantation from 2012 to the date of Institutional Review Board (IRB)/Ethics Committee (EC) approval ofthe original version 1.0 protocol at the study site.
- •Retrospective Expanded Data Collection & Prospective Follow-Up Phase:
- •Subject completed limited retrospective data collection phase and willing to consent to expanded retrospective data collection and the prospective phase of the study;
- •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
- •Retrospective Limited Data Collection/Enrollment Phase:
- •Not applicable
- •Retrospective Expanded Data Collection & Prospective Follow-Up Phase:
- •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 including mental illness, mental retardation, drug or alcohol abuse; or
- •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
Modular stem revision
时间窗: 5 years post operatively
Listing of stem implant status at 5 years to analyze stem survival rate
次要结局
- Revision of any component for any reason(5 year post operative)
- Radiographic assessments(follow-up to 10 years as per standard of care)
- Adverse Events(through study completion, an average of 10 years)
- Harris Hip Score(collect retrospectively from medical record preoperative and if done preoperatively at 1 year, 5 year and 10 year follow up visits)