No registrations found.
ID
Source
Brief title
Health condition
periprosthetic joint infection
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the difference in proportion of infection-free implant survival between the study groups within 1 year of follow-up, as assessed by the independent Data Review Committee, in the mITT population.
Secondary outcome
a. The proportion of SSI and PJI in both study groups during follow-up.
b. The cefazolin susceptibility of the micro-organisms causing SSI and PJI in the study groups.
c. The number of repeated surgeries.
d. The reason for repeated surgery on the affected prosthetic joint during follow-up.
e. Adverse drug events and serious adverse events.
f. Risk factors associated with SSI and PJI.
g. PROMs at weeks 12 and 52.
Background summary
Periprosthetic joint infection (PJI) is an important complication of total joint arthroplasty of the hip and knee and occurs in 1-2% after primary arthroplasty and in 10-15% after revision arthroplasty. To prevent a PJI, peri-operative antibiotic prophylaxis is given. There’s inadequate evidence for a recommendation about the optimal duration of prophylaxis, especially in revision arthroplasty. The aim of this multicenter open-label, randomized controlled trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee.
Study objective
We hypothesize that the extended antibiotic prophylactic regimen is associated with increased infection-free survival of the implant within one year after revision arthroplasty (index revision arthroplasty) compared to a single dose.
Study design
study visits weeks 6, 12, 52.
Intervention
A) Cefazolin at a single dose of 2 grams intravenously 15-60 minutes before incision;
B) Cefazolin at a dose of 2 grams intravenously 15-60 minutes before incision, followed by cefazolin 1 gram intravenously t.i.d. until five days post-surgery.
S aureus dekolonisation
Inclusion criteria
a. Aged 18 years or older.
b. Planned revision arthroplasty of the hip or knee prosthesis (index revision arthroplasty), with revision of one or more fixed components.
Exclusion criteria
a. If the index revision arthroplasty has been cancelled.
b. Revision of single mobile parts only.
c. PJI on baseline, based on ’definite infection’ score according to the Philadelphia consensus definition 2018
d. PJI on baseline, based on a positive culture of a single synovial fluid or tissue sample yielding a high virulence micro-organism (S. aureus, Enterobacterales, Pseudomonas spp, Acinetobacter spp, Candida spp).
e. Contraindication to cefazolin: previous allergic reaction, severe kidney disease defined as eGFR <10 ml/min.
f. Antimicrobial treatment within 3 days prior to index revision arthroplasty.
g. Subjects who are currently enrolled in investigational immunosuppressive drug trials.
h. Subjects who are unable to provide informed consent.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7790 |
| Other | CMO regio Arnhem - Nijmegen : 2019-5544 |