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.
ID
Bron
Verkorte titel
Aandoening
periprosthetic joint infection
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
study visits weeks 6, 12, 52.
Onderzoeksproduct en/of interventie
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
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7790 |
| Ander register | CMO regio Arnhem - Nijmegen : 2019-5544 |