Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty: a Prospective, Randomized Clinical Survey

Conditions
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Infection

Intervention / Treatment
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* Procedure: Arthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Patients receiving single dose of IV cefazolin (2 grams if < 120kg; 3 grams if >120kg) 10-60 minutes before incision | Procedure: Arthroplasty<br>* All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision<br>* Other names: Hip arthroplaty revision;|
| Experimental: Vanco<br>Patients receiving a single dose of IV cefazolin (2 grams if < 120kg; 3 grams if >120kg) 10-60 minutes before incision + a single dose of intra-articular vancomycin powder (1 gram) before articulation (hip or knee) closure | Procedure: Arthroplasty<br>* All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision<br>* Other names: Hip arthroplaty revision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Infection rate | Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term infection rate | Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given | 2 years | 
| Risk factor | Infection rate in patients with risk factors depending on the antibiotic molecule that was given | 2 years | 
| Primary vs revision | Infection rate in primary versus revisions surgery depending on the antibiotic molecule that was given | 2 years | 
| Surgery time | Infection rate according to surgery time depending on the antibiotic molecule that was given | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vancomycine, hip arthroplasty, knee arthroplasty, hip revision arthroplasty, knee revision arthroplasty