Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054711
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2023-09-19
Brief Title:
Joint Aspiration in Dysfunctional Hip Knee or Shoulder Prostheses
Sponsor:
Groupe Hospitalier Diaconesses Croix Saint-Simon
Organization:
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study Overview
Official Title:
Joint Aspiration in Dysfunctional Hip Knee or Shoulder Prostheses Chronic Infection or Implant Failure JAD-Pro
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JAD-Pro
Brief Summary:
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
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
Detailed Description:
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 xray 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
Visit V2 Day of prosthesis revision in the event of chronic PJI or mechanical prosthesis dysfunction Implant failure requiring surgery
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 xray 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
Visit V2 Day of prosthesis revision in the event of chronic PJI or mechanical prosthesis dysfunction Implant failure requiring surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None