The Treatment of the Acute Periprosthetic Hip Infection After Uncemented Total Hip Arthroplasty: A Randomized Study Comparing Open Debridement Component Retention (ODCR) With Modular Exchange Versus One Stage Exchange Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Success
研究概览
简要总结
The purpose of this study is to determine the success rate of two treatments for infection after total hip replacement: single stage arthroplasty exchange (your surgeon will take out your original implants and replace them with a complete new set) compared to irrigation and debridement with modular exchange (your surgeon will clean your implants with a surgical solution and take out the plastic liner and replace it with a new one - the rest of your hip implants will stay in place). The goal is to see if one is better than the other for the treatment of hip infection after a total hip replacement. A successful treatment means that you did not have to have another surgery on your hip for an infection-related reason.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Return to the OR for a drainage procedure within six weeks of index primary uncemented arthroplasty 1a) Exam findings within six weeks of index operation:
- •Drainage for more than 7 days
- •Wound appearance consistent with deep infection or hematoma
- •Persistent fever or evidence of bacteremia
- •All patients currently deemed appropriate for irrigation and debridement
- •Rising inflammatory seromarkers
- •Aspiration with a positive culture
排除标准
- •Previous history of periprosthetic infection
- •Patients not willing to consent for the proposed treatment
- •Patients with altered mental status
- •Concurrent metastatic infection
- •Superficial Infection
结局指标
主要结局
Success
时间窗: 2 year
Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection
次要结局
未报告次要终点