Clinical Follow-up of ASR Patients Post-Recall
试验速览
- 阶段
- 不适用
- 入组人数
- 1,950
- 试验地点
- 13
- 主要终点
- Implant survival rate after hip arthroplasty using DePuy ASR/ASR-XL implants
研究概览
简要总结
DePuy Orthopaedics has issued a voluntary recall of the ASR hip replacement system due to a higher than expected revision rate reported in the England/Wales and Australian national joint registries. There are two types of ASR hip implants used for total hip replacement surgery:
- ASR XL Hip System
- ASR Hip Resurfacing System Massachusetts General Hospital (MGH) in Boston, USA is the study sponsor. MGH is conducting this study with the help of funding from DePuy Orthopaedics. MGH will collect and analyze clinical information from 5,000 subjects around the world. The countries include the United States of America, Australia, South Africa, England, Denmark, Finland and Sweden. MGH will collect and analyze blood test results, X-rays, soft tissue imaging and how well the ASR hips are functioning. MGH will analyze the data annually for 6 years.
The purpose of this study is to follow patients who have the ASR hip system for the next 6 years. The findings of this study may help surgeons to make better informed decisions about monitoring and treatment of patients with ASR hip systems.
详细描述
Description of the Subject Population:
- Adults who have previously undergone a surgery implanting the DePuy ASR XL Acetabular Hip System or ASR Hip Resurfacing System;
- ASR patients who are already being followed-up by their surgeon at least once a year. This routine follow-up care consists of a clinic visit, blood tests, X-rays and possibly an MRI, Ultrasound or CT scan.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Implant survival rate after hip arthroplasty using DePuy ASR/ASR-XL implants
时间窗: From the date of primary hip replacement surgery to the end of the study (up to 6 (+/- 0.5) years after enrollment) or to the date of revision surgery, whichever event occurs first.
To quantify implant failure rates following voluntary recall of the ASR implant
次要结局
- Plain radiographic, ultrasound and/or MRI evaluation(Within 24 months before enrollment, each annual follow-up visit and within 6 months before revision surgery (last images results <= 6.5 years after enrollment date))
- Patient reported outcome scores: UCLA, Harris Hip, Case Mix Indicator and EQ-5D(At enrollment and each of the 5 annual follow-up visits ((last surveys <= 6.5 years after enrollment date, unless there is revision surgery, then at the last annual follow-up visit))
- Incidence of adverse local tissue reaction(On the date of revision surgery, not later than the last, 5 year study follow-up visit (<= 6.5 years after enrollment))
- Cobalt and Chromium ion levels in serum(Within 24 months before enrollment, at each annual follow-up visit; within 6 months before and then within 6 months after revision surgery (last test results <= 7 years after enrollment date))
研究者
Orhun Muratoglu
Co-Director, Harris Orthopedics Laboratory
Massachusetts General Hospital