Microdialysis monitoring of antibiotic release after hip spacer surgery
Analysis of Immunological and Pharmacological Aspects Regarding Infection Free Survival After Surgical Treatment of a Periprosthetic Hip Infection During Hospitalization: a Microdialysis Study
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bonn Academic / other |
| Locations | 1 site (Bonn, North Rhine-Westphalia) |
| Trial ID | NCT07299591 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bonn, North Rhine-Westphalia
- 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
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.