The primary objective is to determine the penetration of cefazolin and clindamycin in synovial fluid and bone tissue related to the serum concentration in subjects undergoing reimplantation of the hip.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the ratio (%) of the concentration of cefazolin and
clindamycin in synovial fluid and bone tissue to serum. The ratio*s will be
calculated for different time points after the infusion of the agents.
Secondary outcome
The secondary parameters are the concentration of cefazolin and clindamycin
related to the MIC90 of micro-organisms that frequently causes PJI.
Background summary
Periprosthetic joint infection (PJI) is a feared complication of joint
replacement, with an incidence of 0.5-1% after primary joint replacement and
3-5% after revision arthroplasty. For orthopaedic surgery involving a
prosthesis, the administration of systemic antibiotic prophylaxis is strongly
recommended to prevent PJI. Cefazolin is widely used as agent of choice in
surgical antibiotic prophylaxis. Previous studies, all performed in patients
undergoing primary joint replacement, demonstrated that the concentration of
cefazolin in bone and synovial fluid was dose-dependent and exceeds the MIC90
for methicillin susceptible Staphylococcus aureus (MSSA), when given as 1 to 4
gram single dose shortly before incision. When a PJI is already present,
clindamycin is used as treatment option in PJI caused by staphylococci (when
combined with rifampicin) or cutibacteria. A limited number of studies have
been performed to analyse the penetration of clindamycin into bone. These
studies showed that clindamycin penetrates well into the bone and
concentrations exceeded the MIC90 for MSSA. No studies have been performed to
analyse the penetration of antibiotic agents into the periarticular tissue in
patients who will undergo revision arthroplasty. In revision arthroplasty a
foreign body (prosthesis) is in situ and periarticular tissue condition can be
compromised due to previous surgical procedures and the presence of bone
reaction to the prosthesis. It is not known whether the difference in PJI
incidence after primary and revision arthroplasty may be explained by different
penetration of the surgical antibiotic prophylaxis. The aim of this explorative
study is to analyse the penetration of cefazolin and clindamycin into synovial
fluid and bone and whether the concentration of the agents exceeds the MIC90
for micro-organisms frequently causing PJI.
Study objective
The primary objective is to determine the penetration of cefazolin and
clindamycin in synovial fluid and bone tissue related to the serum
concentration in subjects undergoing reimplantation of the hip.
Study design
This is an explorative observational study
Study burden and risks
Subject will receive the cefazolin antibiotic prophylaxis and clindamycin
antibiotic therapy as part of standard of care. Study interventions will be
sampling of the serum, synovial puncture and bone tissue. The risk of serious
side effect due to the study interventions is considered low. Before opening
the joint, synovial fluid will be collected by synovial puncture. This will not
influence the risk of infection and will not damage the joint, because the
capsular will be opened by incision after synovial aspiration as part of the
revision procedure. During the procedure, additional serum samples and 2 bone
samples will be taken. The bone samples will be very small (<5mm), which will
not influence the stability of the bone. The risk for the subject is considered
low and the additional knowledge that we will be acquired by this study is
important to learn more about the difference in risk of PJI after primary and
revision arthroplasty.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-001273-31-NL |
| CCMO | NL81050.091.22 |