Overview
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.
Eligibility
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