Using vancomycin powder to reduce infection in hip and knee surgeries
Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty: a Prospective, Randomized Clinical Survey
This study is testing if adding vancomycin powder during hip and knee surgeries can help reduce the risk of infections compared to just using cefazolin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1832 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT04399642 on ClinicalTrials.gov |
What this trial studies
This study aims to compare infection rates in patients undergoing primary or aseptic revision total hip or knee arthroplasty. Participants will be randomly assigned to receive either a single intravenous dose of cefazolin or the same intravenous dose combined with intra-articular vancomycin powder before the surgical closure. The study will involve 1834 subjects over a period of approximately two years, focusing on selected outcome measurements related to infection rates. The goal is to determine if the addition of intra-articular vancomycin can significantly lower the risk of postoperative infections.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old scheduled for primary or aseptic revision total hip or knee arthroplasty.
Not a fit: Patients with active infections, known allergies to vancomycin, or those unable to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce infection rates in patients undergoing hip and knee arthroplasty.
How similar studies have performed: Other studies have shown promising results with intra-articular antibiotics in reducing infection rates, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montréal, Quebec
- Hopital Sacré-Coeur de Montreal — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Benoit Benoit, MD — CIUSSS du Nord de l'Île de Montreal
- Study coordinator: Benoit Benoit, MD
- Email: ben1000ben@icloud.com
- Phone: 514-338-2222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.