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Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

Infection

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation Criteria

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

Study Location

Hopital Sacré-Coeur de Montreal
Hopital Sacré-Coeur de Montreal
Montréal, Quebec
Canada

Contact Study Team

Backup Contact

Karine Tardif

[email protected]
514-338-2222
Primary Contact

Benoit Benoit, MD

[email protected]
514-338-2222
Study Sponsored By
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Participants Required
More Information
Study ID: NCT04399642