Status:
ACTIVE_NOT_RECRUITING
Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty
Lead Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Conditions:
Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 antibi...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1832 Patients enrolled
Trial Details
Trial ID
NCT04399642
Start Date
July 5 2019
End Date
December 31 2027
Last Update
September 11 2025
Active Locations (1)
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1
Hopital Sacré-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5