Comparison of long versus short antibiotic prophylaxis to prevent infection of the prosthesis of hip or knee after revision surgery.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002438-35-NL

Enrollment

780

Registered

2019-06-25

Start date

2019-09-16

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Prevention of periprosthetic joint infection on patients undergoing revision surgery of the hip or knee. MedDRA version: 20.0 Level: LLT Classification code 10057129 Term: Revision of total knee arthroplasty System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10057128 Term: Revision of hip arthroplasty System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10049924 Term: I

Interventions

Trade Name: Kefzol Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion Trade Name: kefzol Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Planned revision arthroplasty of the hip or knee prosthesis, with revision of one or more fixed components Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 530

Exclusion criteria

Exclusion criteria: Periprosthetic joint infection on baseline

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to investigate whether an extended regimen compared to a single dose of cefazolin is associated with an increased infection-free implant survival within one year after index revision arthroplasty of the hip or knee. ;Secondary Objective: The secondary objectives include the determination of the incidence, risk factors, treatment outcome and prognosis of Surgical side infecion (SSI) and periprosthetic joint infectin (PJI) during follow-up. The safety and tolerance of the regimens, and the antimicrobial susceptibility patterns of microorganisms will be described. Patient reported outcome measures (PROMs) will be used to evaluate physical performance and satisfaction of subjects within 1 year after the index revision arthroplasty. A costutility analysis will only be performed when the primary outcome has demonstrated superiority of the extended regimen. ;Primary end point(s): The primary endpoint is the difference in proportion of infection-free implant survival between the study groups after 1 year of follow-up, as assessed by the independent Data Review Committee, in the mITT population. ;Timepoint(s) of evaluation of this end point: One year after revision arthroplasty	—

Measure

Time frame

Main Objective: The primary objective is to investigate whether an extended regimen compared to a single dose of cefazolin is associated with an increased infection-free implant survival within one year after index revision arthroplasty of the hip or knee. ;Secondary Objective: The secondary objectives include the determination of the incidence, risk factors, treatment outcome and prognosis of Surgical side infecion (SSI) and periprosthetic joint infectin (PJI) during follow-up. The safety and tolerance of the regimens, and the antimicrobial susceptibility patterns of microorganisms will be described. Patient reported outcome measures (PROMs) will be used to evaluate physical performance and satisfaction of subjects within 1 year after the index revision arthroplasty. A costutility analysis will only be performed when the primary outcome has demonstrated superiority of the extended regimen. ;Primary end point(s): The primary endpoint is the difference in proportion of infection-free implant survival between the study groups after 1 year of follow-up, as assessed by the independent Data Review Committee, in the mITT population. ;Timepoint(s) of evaluation of this end point: One year after revision arthroplasty

—

Secondary

Measure	Time frame
Secondary end point(s): 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;Timepoint(s) of evaluation of this end point: Within one year after revision arthroplasty	—

Measure

Time frame

Secondary end point(s): 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;Timepoint(s) of evaluation of this end point: Within one year after revision arthroplasty

—

Countries

Netherlands

Contacts

Public ContactClinical trials information

Radboudumc

sandra.eichelsheim@radboudumc.nl0031243614763

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026