Microdialysis monitoring of antibiotic release after hip spacer surgery
Official title: Analysis of Immunological and Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Hip Infection During Hospitalization: a Microdialysis Study
Run by University Hospital, Bonn · NCT07299591 · Data updated 2026-11-12
This project will use microdialysis to test whether antibiotics released from a cement spacer reach therapeutic levels in the hip joint and relate to infection-free recovery in adults having two-stage revision for periprosthetic hip infection.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University Hospital, Bonn Academic / other |
| Locations | 1 site (Bonn, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | November 15, 2025 |
| Main results expected | November 1, 2026 |
| Study ends | November 1, 2027 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07299591 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) scheduled for two-stage revision for periprosthetic hip infection at the University Hospital Bonn who can provide informed consent and are not allergic to gentamicin or vancomycin.
✕Probably not a fit
Patients with known allergy to gentamicin or vancomycin, those managed with single-stage or non-surgical approaches, or those unable to remain hospitalized for the monitoring period are unlikely to benefit from this protocol.
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 hip joint after removal of an infected prosthesis and implantation of an antibiotic-loaded cement spacer to continuously sample local drug and immune markers during the initial hospitalization (typically about 14 days). Parallel blood sampling will compare systemic and intraarticular concentrations of the spacer antibiotics gentamicin and vancomycin. Local and systemic pharmacologic profiles will be correlated with reinfection rates, infection-free survival, and functional outcomes over a 12-month follow-up. The protocol builds on a prior 72-hour pilot demonstrating feasibility but extends monitoring across the full spacer period to better understand sustained antibiotic elution and clinical implications.
Why it matters
Potential benefit: If successful, the findings could help tailor spacer antibiotic selection and dosing to reduce reinfection rates and improve recovery after two-stage hip revision.
How similar studies have gone: A prior small pilot by the same group showed microdialysis is feasible for 72-hour monitoring, but extended in vivo monitoring over the entire spacer period is novel and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinical indication for two-stage revision of hip 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
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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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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.