Retrieval and Analysis of Orthopedic Implants at Revision Arthroplasty Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- determine the mechanism of material failure
研究概览
简要总结
The goal of this is to improve durability of total joint replacements in patients, thereby improving clinical outcomes and implant performance. To reach this objective, our research program would like to assess the safety, efficacy, performance, and durability of FDA approved biomaterial and implant designs used in joint replacements.
详细描述
The objective of the investigation will be to determine the mechanism of material failure and identify any design features that put the implant at risk for early failure. Normally all implants are discarded. The investigators will collect the implants indicated for removal and if there are impressive findings the investigators will perform research on the implants, otherwise the implants will be discarded. All patients will be followed prospectively after informed consent is signed. The implants that are chosen for research will be assessed for implant wear and failure at a lab appropriate for evaluating the particular concern.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who will be undergoing revision total joint surgery will be asked to participate in this study.
排除标准
- •Patients who are not undergoing revision total joint surgery.
结局指标
主要结局
determine the mechanism of material failure
时间窗: 10 years
次要结局
- identify any design features that put the implant at risk for early failure.(10 years)
研究者
Christopher Peters
M.D.
University of Utah