跳至主要内容
临床试验/NCT06054711
NCT06054711招募中不适用

Joint Aspiration in Dysfunctional Hip, Knee or Shoulder Prostheses (Chronic Infection or Implant Failure) "JAD-Pro"

Groupe Hospitalier Diaconesses Croix Saint-Simon2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
2
主要终点
Analysis of the bacteriological concordance between JFA and perioperative samples

研究概览

简要总结

After a hip, knee or shoulder arthroplasty, the evolution is not always favorable. It can be marked by an infectious or non-infectious complication, most often implant failure. In this context, joint fluid aspiration (JFA) is indicated to document a prosthetic joint infection (PJI) or to bring to light arguments for implant failure. Nevertheless, opinions differ on its indication for microbiological identification. Some teams perform it systematically when faced with a prosthesis dysfunction. Others, only in the presence of suggestive signs of PJI. Finally, others never perform it.

Based on clinical, radiological and biological (CRP) signs, at the preoperative stage and before JFA, we classify our patients into 3 groups: supposedly septic (chronic joint infection), supposedly aseptic (implant failure) or intermediate (Unknown). This last group, often encountered in consultation, poses a diagnosis problem more than the others.

In our experience, JFA is an essential diagnosis tool in these 3 groups of patients. It helps to choose the surgical strategy. In addition, the dosage of biomarkers in the joint fluid as the alpha defensin, the leucocyte esterase and the CRP could provide an additional argument to investigate the infectious origin or not, in particular in difficult cases.

In summary, the disagreement on the usefulness of JFA in case of PJI suspicion and any other prosthetic dysfunction, the lack of data on large prospective studies and our questioning about the contribution of JFA in the aseptic and intermediate group of patients, motivated us to set up this study to evaluate the interest of the JFA for the preoperative diagnosis, as well as that of the dosage of biomarkers in the joint fluid.

详细描述

Visit V0: corresponds to the first consultation. After informing and obtaining the consent of the patient, the investigator will collect the anamnesis, clinical, radiological and biological data, then will indicate the anticipated medico-surgical strategy. The FJA will be prescribed during this consultation, as well as the dosage of the CRP in blood the same day as the FJA.

Then, the investigator will classify the patient (primary classification) in one of the three groups the groups: supposedly septic, supposedly aseptic or intermediate.

A reclassification of patients (secondary classification) will be done, based on the bacteriological results of the FJA (positive, negative and doubtful). Biomarker results will not be disclosed or considered for patient care.

Visit V1: corresponds to the day of the FJA in the x.ray department and the blood sample in the central laboratory for the CRP dosage.

During FJA, 2 ml of additional joint fluid will be collected in addition to the volume usually collected for CRP, Leukocyte Esterase and alpha defensin dosage in joint fluid. Alpha defensin dosage will be performed only in patients in the intermediate group with a negative FJA.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Patient consent to participate in the study.
  • Patient aged over 18 years
  • Patient with hip, knee or shoulder joint prosthesis
  • Patient who has the Indication to perform a FJA, whatever the cause of revision (mechanical, septic)
  • Over one-month symptoms evolution for patients suspected of infection

排除标准

  • Acute prosthesis infection with less than one-month symptoms' duration
  • Antibiotic therapy between preoperative FJA and intraoperative samples
  • Pregnant or breastfeeding woman.

结局指标

主要结局

Analysis of the bacteriological concordance between JFA and perioperative samples

时间窗: From JFA till perioperative samples bacteriological analysis termination

Number of patients whose JFA is concordant with that of the perioperative samples

次要结局

未报告次要终点

研究者

发起方
Groupe Hospitalier Diaconesses Croix Saint-Simon
申办方类型
Other
责任方
Principal Investigator
主要研究者

SMARMOR

Director

Groupe Hospitalier Diaconesses Croix Saint-Simon

研究点 (2)

Loading locations...

相似试验