Multiple doses versus single dose of cefazolin to prevent periprosthetic joint infection after revision arthroplasty: a multicenter open-label, randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22317

Enrollment

780

Registered

2019-06-08

Start date

2019-09-02

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

periprosthetic joint infection

Interventions

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

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactKarin Veerman

Radboudumc / Sint Maartenskliniek

karin.veerman@radboudumc.nl0031683845606

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)