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

Phase 4

Completed

• Conditions: joint infection; prosthetic joint infection; 10004018; 10005944

• Registration Number: NL-OMON48292
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 780

Inclusion Criteria

planned revision arthroplasty of the prosthesis of the hip or knee for
non-infectious reason

Exclusion Criteria

periprosthetic joint infection on baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the difference in proportion of infection-free implant<br /><br>survival between the study groups within 1 year of follow-up, as assessed by<br /><br>the independent Data Review Committee, in the mITT population. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives include the determination of the incidence, risk<br /><br>factors, treatment outcome and prognosis of SSI and PJI during follow-up. The<br /><br>safety and tolerance of the regimens, and the antimicrobial susceptibility<br /><br>patterns of microorganisms will be described. Patient reported outcome measures<br /><br>(PROMs) will be used to evaluate physical performance and satisfaction of<br /><br>subjects within 1 year after the index revision arthroplasty. A cost-utility<br /><br>analysis will only be performed when the primary outcome has demonstrated<br /><br>superiority of the extended regimen. </p><br>