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

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10064736Term: Antibiotic prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10057129Term: Revision of total knee arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10057128Term: Revision of hip arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10049924Term: Infection prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; Prevention of periprosthetic joint infection on patients undergoing revision surgery of the hip or knee.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-002438-35-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-25
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 780

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

Periprosthetic joint infection on baseline

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified