Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Status: Enrolling

Conditions: Infection

Treatments: Procedure: Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04399642

Single-Dose

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,832 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,832 participants in 2 patient groups

Standard

Active Comparator group

Description:

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

Treatment:

Procedure: Arthroplasty

Vanco

Experimental group

Description:

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

Treatment:

Procedure: Arthroplasty