Periarticular penetration of cefazolin and clindamycin in second stage revision arthroplasty of the hip.
Phase 4
- Conditions
- periarticular penetration antibiotics10023213
- Registration Number
- NL-OMON51548
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Age 18 years or older.
2. Scheduled second stage revision arthroplasty (reimplantation) of the hip
prosthesis preferably during clindamycin 600mg three times a day orally for
PJI, started at least 3 days before reimplantation.
Exclusion Criteria
1. Antibiotic prophylaxis other than cefazolin 2000mg i.v.
2. Cefazolin use within 4 days previous to the reimplantation, other than the
single dose administration of surgical prophylaxis just before incision.
3. Clindamycin loaded bone cement in situ.
4. BMI more than 35 kg/m2.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the ratio (%) of the concentration of cefazolin and<br /><br>clindamycin in synovial fluid and bone tissue to serum. The ratio*s will be<br /><br>calculated for different time points after the infusion of the agents.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary parameters are the concentration of cefazolin and clindamycin<br /><br>related to the MIC90 of micro-organisms that frequently causes PJI. </p><br>