Joint Aspiration in Dysfunctional Hip, Knee or Shoulder Prostheses

NCT06054711 | Unknown

• 1 other identifier: 2020-A00466-33
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Prosthesis; Complications

Outcome Measures

Primary Outcomes (1)

• Analysis of the bacteriological concordance between JFA and perioperative samples

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

  From JFA till perioperative samples bacteriological analysis termination

Study Arms (1)

Joint Fluid Aspiration

OTHER

all included patients reporting prothesis complication will undergo a joint fluid aspiration

Other: joint puncture

Interventions

joint puncture OTHER

Patients reporting complications such as pain hindering mobility or affecting quality of life, or any other symptoms suspecting prosthesis failure or infection will undergo joint fluid aspiration.

Joint Fluid Aspiration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe Hospitalier Diaconesses Croix saint Simon

Paris, 75020, France

RECRUITING

MeSH Terms

Interventions

Arthrocentesis

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Simon MARMOR, MD

  Groupe Hospitalier Diaconesses Croix Saint-Simon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Younes KERROUMI, MD

CONTACT

+33144643384; ykerroumi@hopital-dcss.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Prospective cohorte study

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: February 7, 2022
• Primary Completion: February 7, 2024
• Study Completion: August 7, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

FR (1)