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临床试验/NCT01712880
NCT01712880撤回不适用

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

OrthoCarolina Research Institute, Inc.1 个研究点 分布在 1 个国家开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
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

研究组 & 干预措施

open debridement with modular exchange

Active Comparator

干预措施: open debridement with modular exchange (Procedure)

one stage exchange

Active Comparator

干预措施: one stage exchange (Procedure)

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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