Cohort of patients with prosthetic joint infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to manage and monitor patients with prosthetic joint infections (PJI) at a French referral center. It includes patients over 18 years old who have undergone various treatment strategies for PJI, such as debridement-synovectomy or exchange arthroplasty, and those receiving prolonged suppressive antibiotic therapy. The study will follow participants for at least two years to assess outcomes like reinfection rates, joint revisions, and mortality related to PJI. The study spans a total duration of 10 years, with a recruitment period of 4 years and a maximum data collection period of 6 years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient aged over 18 years old with hip, knee and or shoulder joint prosthesis who consented to participate in the study with:
* According to musculoskeletal infection society definition: PJI is present when one of the major criteria exists or four out of six minor criteria.

Major Criteria:

* Two positive periprosthetic cultures with phenotypically identical organisms, OR
* A sinus tract communicating with the joint, OR

Minor Criteria:

* Elevated serum C-reactive protein (CRP) AND erythrocyte sedimentation rate (ESR)
* Elevated synovial fluid white blood cell (WBC)
* Elevated synovial fluid polymorphonuclear neutrophil percentage (PMN%)
* The presence of pus in the joint without known cause
* Positive histological analysis of periprosthetic tissue
* A single positive culture

Or a PJI which meets the following three criteria:

* Medical story suggesting prosthetic joint infection.
* The presence of pain either with or without swelling for more than 3 months unrelated to a mechanical cause.
* Germ identification in a single sample of fluid aspiration or tissue culture.

  * Or microbial growth in prosthesis sonication fluid culture greater than 50CFU/ml.

Exclusion Criteria:

* Patient who does not meet eligibility criteria.
* Patient lawfully deprived of his liberty.
* Patient not insured under social security scheme.

Where it's running

• Groupe Hospitalier Diaconesses Croix Saint Simon
  Paris, Île-de-France Region, France Recruiting

Study contacts

• Principal investigator: VALERIE ZELLER, Doctorate — Groupe Hospitalier Diaconesses Croix Saint-Simon
• Study coordinator: YOUNES KERROUMI, Doctorate
• Email: ykerroumi@hopital-dcss.org
• Phone: (+33) 1 64 44 33 84

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.