Periprosthetic Knee Infection
Conditions
Keywords
two-stage exchange, infection, arthroplasty, PJI, microdialysis, minimal inhibitory concentration, bone cement, treatment monitoring
Brief summary
The goal of this observational study is to monitor the eluted antibiotic concentrations of gentamicin and vancomycin by a static knee cement spacer in patients being treated for periprosthetic infections of the knee. The main question aims to answer if eluted antibiotics are in a therapeutic range for treatment at sight of infection. Secondarily, local antibiotic concentrations are compared with systemic blood levels, as are systemically applied antibiotics compared to intra-articular concentrations. Intra-articular samples are collected over a 72 hour postoperative period.
Detailed description
The present study moinitors antibiotic concentrations eluted by a static cement knee spacer as two-stage revision treatment of a knee PJI. The static cement spacer consists of COPAL G+V cement containing 2g of vancomycin and 0.5g of gentamicin. Microdialysis is used as a technique for continuous extra cellular sample collection directly from the knee joint cavity. It is implemented guided by a drainage tube during the surgery to remove the infected prosthesis and implement the spacer. Over a 72 hour period samples directly from the knee joint are generated continiously. These are analyzed for the eluded antibiotic concentrations of gentamicin and vancomycin from the knee spacer. Once every 24 hours venous blood samples were collected as well and analyzed for gentamicin and vancomycin and also systemically applied antibiotics (a.e. cefuroxim, clindamycin).
Interventions
DEVICEIntraarticular microdialysis
The intervention decive is placed during the routine surgery to remove the infected knee prosthesis and implantation of the static cement spacer. A microdialysis catheter is implemented to generate continious intra-articular samples of the knee joint. To ensure complete removal and no damage of the membrane it is inserted via a regular drainage tube. The catheter membrane is placed intra-articularly next to the spacer and continious to an outlet tube for sample collection.
Sponsors
University Hospital, Bonn
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinical indication for a two-staged revision of a knee PJI * approval for surgery by the orthopedic and anesthesiologic departments * 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 the antibiotics gentamicin and vancomycin contained in the spacer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| antibiotic concentrations in intra-articular samples | Concentrations are measured for 72 hours after spacer implantation. | Both locally through the spacer eluted antibiotics (gentamicin and vancomycin) and systemically administered antibiotics (e.g. cefuroxim, clindamycin) are measured in intra-articular knee samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic concentrations in blood samples | Antibiotic concentrations are measured once every 24 hours after spacer implantation. In total at three time points during the 72 hour observation period. | Antibiotic concentrations eluted by the spacer (gentamicin, vancomycin) and systemically administered antibiotics (e.g. cefuroxim, clindamycin) are measured in venous blood samples. |
Countries
Germany
Outcome results
None listed