Joint fluid aspiration for hip, knee, or shoulder prosthesis issues
Joint Aspiration in Dysfunctional Hip, Knee or Shoulder Prostheses (Chronic Infection or Implant Failure) "JAD-Pro"
This study is testing if taking fluid out of the hip, knee, or shoulder joint can help doctors figure out if there are problems with joint replacements, like infections or failures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06054711 on ClinicalTrials.gov |
What this trial studies
This study evaluates the role of joint fluid aspiration (JFA) in diagnosing complications related to hip, knee, or shoulder prostheses. Patients will be classified into three groups based on clinical, radiological, and biological data: supposedly septic, supposedly aseptic, or intermediate. The study aims to determine the effectiveness of JFA in identifying prosthetic joint infections or implant failures. Participants will undergo JFA and subsequent analysis of joint fluid to guide treatment decisions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with hip, knee, or shoulder prostheses experiencing complications requiring joint fluid aspiration.
Not a fit: Patients with acute prosthesis infections of less than one month or those undergoing antibiotic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve diagnostic accuracy and treatment outcomes for patients with prosthetic joint complications.
How similar studies have performed: While the use of joint fluid aspiration is common, this specific classification approach has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Exclusion Criteria: * Acute prosthesis infection with less than one-month symptoms' duration * Antibiotic therapy between preoperative FJA and intraoperative samples * Pregnant or breastfeeding woman.
Where this trial is running
Paris
- Groupe Hospitalier Diaconesses Croix saint Simon — Paris, France (Recruiting)
Study contacts
- Principal investigator: Simon MARMOR, MD — Groupe Hospitalier Diaconesses Croix Saint-Simon
- Study coordinator: Younes KERROUMI, MD
- Email: ykerroumi@hopital-dcss.org
- Phone: +33144643384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.