Bacteriological Setting Before Prosthesis Implantation With One Stage Surgery in Prosthetic Joint Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The number of patients with positive per-operative sample culture after surgical excision and antibiotic initiation and prior prosthesis implantation
研究概览
简要总结
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.
详细描述
Study duration: Two weeks. Recruitment period: 18 months. Maximal duration of data collection: Two weeks. Investigator center: monocenter study. Mean patient inclusion per year: 70 patients per year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: intraoperative samples (Procedure)
结局指标
主要结局
The number of patients with positive per-operative sample culture after surgical excision and antibiotic initiation and prior prosthesis implantation
时间窗: 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.
次要结局
- Description of outcomes of perioperative sample culture prior surgical excision in patients treated with preoperative antibiotherapy.(18 months)
- Description of outcomes of perioperative sample culture after surgical excision according to the identified germ in culture before excision.(18 months)
- Description of outcomes of perioperative sample culture after surgical excision according to antibiotherapy duration from initiation until perioperative samples.(18 months)
- Description of outcomes of perioperative sample culture according to symptoms duration prior surgery.(18 months)
- Description of microbiological evolution of preoperative and perioperative samples before and after surgical excision.(18 months)
研究者
SMARMOR
Orthopaedic surgeon
Groupe Hospitalier Diaconesses Croix Saint-Simon