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Joint Aspiration in Dysfunctional Hip, Knee or Shoulder Prostheses

NCT06054711 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2023-09-26

No results posted yet for this study

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

Interventions

OTHER

joint puncture

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.

Sponsors & Collaborators

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    lead OTHER

Principal Investigators

  • Simon MARMOR, MD · Groupe Hospitalier Diaconesses Croix Saint-Simon

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2024-02-07
Completion
2024-08-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06054711 on ClinicalTrials.gov