Monitoring antibiotic and immune activity in the knee after removal of an infected prosthesis and placement of an antibiotic spacer

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 study places microdialysis probes in the knee joint after removal of an infected prosthesis and insertion of an antibiotic-impregnated cement spacer to continuously sample local antibiotic concentrations and immunologic markers during the initial hospitalization (typically about 14 days). Blood samples will be collected in parallel to compare systemic and intraarticular antibiotic levels. Clinical outcomes, including reinfection rates, infection-free survival, and functional recovery, will be tracked over a 12-month follow-up. The spacer materials contain gentamicin and vancomycin, and patients with known allergies to these antibiotics are excluded. Data will be analyzed to identify pharmacological and immunological profiles associated with better or worse outcomes after two-stage revision.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* clinical indication for two-stage revision of knee PJI
* approval for surgery by the orthopedic and anesthesiologic department
* being over 18 years of age
* written, informed consent after detailed patient information about the study protocol and possible study dependent risks

Exclusion Criteria:

* known allergies to antibiotics gentamicin and vancomycin used within the spacer

Where it's running

• University Hospital Bonn
  Bonn, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Study coordinator: Alexander Franz, Dr. med., B. Sc.
• Email: alexander.franz@ukbonn.de
• Phone: +491703750718

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.