Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    1832
  • sponsor
    Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Updated on 21 July 2021

Summary

The purpose of this study is to compare infection rates when patients, elected for primary or aseptic revision THA / TKA, have a single intravenous antibiotic dose versus one single intravenous antibiotic dose in combination with intra-articular antibiotics. This is a prospective, randomized clinical survey on selected outcome measurements on 1834 subjects who will be recruited in a period of about 2 years.

Description

Group A: patients receiving single dose of IV cefazolin 10-60 minutes before incision.

Group B: patients receiving a single dose of IV cefazolin 10-60 minutes before incision + a single dose of intra-articular vancomycin powder before articulation (hip or knee) closure.

Details
Condition Infection, Infection
Treatment arthroplasty
Clinical Study IdentifierNCT04399642
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Standard criteria for the implantation of primary total hip or knee replacement
Revision of an aseptic THA or TKA
Adults >18 years of age
Diagnosis of Osteoarthrosis (OA), Osteonecrosis (ON), Arthritis; or aseptic loosening of THA/TKA
Subject is willing to consent to participate in the study
Subject is available for follow-up through at least 2 years
Subject has met acceptable preoperative medical clearance and is free of or treated for medical conditions that would pose excessive operative risk
Subject who are fluent in English and / or French and able to understand their role in the study

Exclusion Criteria

Active, local infection or systemic infection
Participation in any other pharmaceutical, biologic or medical device clinical investigation
Subjects with known allergy to vancomycin
Subjects unable to consent
Patient with skin pathology
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