Informations générales (source: ClinicalTrials.gov)

NCT06054711 Statut inconnu
Joint Aspiration in Dysfunctional Hip, Knee or Shoulder Prostheses (Chronic Infection or Implant Failure) "JAD-Pro"
Interventional
N/A
Groupe Hospitalier Diaconesses Croix Saint-Simon (Voir sur ClinicalTrials)
février 2022
août 2024
30 septembre 2025
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.
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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
GRPE HOSP DIACONESSES-CROIX ST-SIMON Simon MARMOR, MD En recrutement IDF Contact (sur clinicalTrials)

Critères

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Inclusion Criteria:

- 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



- Acute prosthesis infection with less than one-month symptoms' duration

- Antibiotic therapy between preoperative FJA and intraoperative samples

- Pregnant or breastfeeding woman.