Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection (Bac-UP)
Chronic prosthetic joint infection (PJI) is a devastating complication of arthroplasty and its treatment continues to fuel the debate on how to manage it appropriately.
One stage and two stage exchange surgery both are the conventional surgical procedures for chronic PJI commonly used to date.
Two stage surgery disadvantages (major surgery, anesthesia and nosocomial risks, functional impairment between surgeries and a high socio-economic coast) encouraged many surgical teams to adopt one stage exchange surgery which provides equivalent or better outcomes. However one stage surgery encounters a major conceptual difficulty when it comes to implant the new prosthesis in a surgical site microbiologically undetermined and potentially contaminated.
Investigators suppose the new prosthesis is implanted in a contaminated setting regardless of bacteria type and antibiotic therapy duration before arthroplasty.
The total lack of data answering this question motivated the conception of this prospective study in order to describe the microbiological setting where is implanted the new prosthesis with one stage exchange surgery after surgical excision and antibiotic therapy initiation in chronic PJI.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Ile De France
-
Paris、Ile De France、法国、75020
- Groupe Hospitalier Diaconesses Croix Saint Simon
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient consent
- Aged over 18 years
- PJI documented preoperatively by joint fluid culture according to Musculoskeletal Infection Society Definition
- Monoarticular PJI
- PJI management validated at the weekly cross-disciplinary conciliation meeting
- PJI treated with one stage surgery and intravenous antibiotherapy adjusted to preoperative aspiration results.
Exclusion Criteria:
- patient who does not meet eligibility criteria
- Negative preoperative aspiration culture
- PJI du to fungi
- Patient lawfully deprived of his liberty
- Patient insured under social security scheme
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Intraoperative samples
During this study of health care procedure evaluating microbiological setting in PJI prior prosthesis implantation with one stage surgery, 3 additional perioperative samples will be performed prior prosthesis implantation for every patient.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The number of patients with positive per-operative sample culture after surgical excision and antibiotic initiation and prior prosthesis implantation
大体时间：18 months
|
In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism.
For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.
|
18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Description of microbiological evolution of preoperative and perioperative samples before and after surgical excision.
大体时间：18 months
|
In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism.
For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.
|
18 months
|
|
Description of outcomes of perioperative sample culture after surgical excision according to the identified germ in culture before excision.
大体时间：18 months
|
In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism.
For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.
|
18 months
|
|
Description of outcomes of perioperative sample culture after surgical excision according to antibiotherapy duration from initiation until perioperative samples.
大体时间：18 months
|
In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism.
For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.
|
18 months
|
|
Description of outcomes of perioperative sample culture prior surgical excision in patients treated with preoperative antibiotherapy.
大体时间：18 months
|
In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism.
For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.
|
18 months
|
|
Description of outcomes of perioperative sample culture according to symptoms duration prior surgery.
大体时间：18 months
|
In routine care procedure for prosthetic joint infection (PJI), at least, five intraoperative samples are taken before debridement and prosthesis removal in order to identify the causative organism.
For the purpose of this study three additional intraoperative samples will be performed after debridement and antibiotic initiation and prior prosthesis implantation.
|
18 months
|
合作者和调查者
调查人员
- 首席研究员：Simon MARMOR, Doctorate、Groupe Hospitalier Diaconesses Croix Saint-Simon
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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