About this trial
This study aims to use the technique of microdialysis to analyse the intraarticular space of the hip joint after removal of a periprosthetic joint infection affected endoprosthesis and implantation of an antibiotic-containing cement spacer over the entire period of the first hospitalization (usually 14 days) to closely monitor pharmacological and immunological aspects. In detail, antibiotic concentrations in the joint cavity and systemic circulation will be assessed according to reinfection rates, infection-free survival and fucntional outcome over a 12-month folluw-up period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
- known allergies to antibiotics gentamicin and vancomycin used within the spacer
Trial population
30 patients over 18 years of age presenting with PJI after total hip arthroplasty and indication for prosthesis explantation and temporary spacer implantation
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Intraarticular concentrations of local antibiotics
Microdialysis will help to generate intraarticular hip joint samples after removal of an infectes prosthesis and spacer implantation. These samples will be analysed for spacer eluted antibiotics.
Secondary outcomes
Comparison intraarticular antibiotic concentrations to venous blood concentrations
Antibiotic concentrations measured in intraarticular samples generated by microdialysis will be compared to venous blood serum concentrations
Other outcomes
Correlation between infection free survival and antibiotic concentrations
Analyzed concentrations of local and systemic antibiotic concentrations will be correlated with infection free survival within the follow up (infection free survival: successfull wound healing, no signs of lossening within X-rays, no increase of inflammatory markers).
Sponsors and contacts
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