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

Conditions: periprosthetic joint infection

Registration Number: NL-OMON22317

Lead Sponsor: Radboudumc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 780

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
a.The proportion of SSI and PJI in both study groups during follow-up.<br>b.The cefazolin susceptibility of the micro-organisms causing SSI and PJI in the study groups.<br>c.The number of repeated surgeries.<br>d.The reason for repeated surgery on the affected prosthetic joint during follow-up.<br>e.Adverse drug events and serious adverse events.<br>f.Risk factors associated with SSI and PJI.<br>g.PROMs at weeks 12 and 52.<br>