Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

Not Applicable

Recruiting

• Conditions: Infection
• Interventions: Procedure: Arthroplasty

• Registration Number: NCT04399642
• Lead Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

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 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

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.

Study Timeline

• Study Start: 2019-07-05
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-13
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1832

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Arthroplasty	Patients receiving single dose of IV cefazolin (2 grams if \< 120kg; 3 grams if \>120kg) 10-60 minutes before incision
Vanco	Arthroplasty	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

Primary Outcome Measures

Name	Time	Method
Acute Infection rate	3 months	Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Sacré-Coeur de Montreal; 🇨🇦 Montréal, Quebec, Canada