Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

NCT04399642 | Active Not Recruiting

• 1 other identifier: Single-Dose
• Study Type: interventional
• Target: 1,832
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

vancomycine; hip arthroplasty; knee arthroplasty; hip revision arthroplasty; knee revision arthroplasty

Outcome Measures

Primary Outcomes (1)

• Acute Infection rate

  Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given

  3 months

Secondary Outcomes (4)

• Long-term infection rate

  2 years

• Risk factor

  2 years

• Primary vs revision

  2 years

• Surgery time

  2 years

Other Outcomes (2)

• The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  baseline, 1 year

• EQ-5D-5L

  baseline, 1 year

Study Arms (2)

Standard

ACTIVE COMPARATOR

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

Procedure: Arthroplasty

Vanco

EXPERIMENTAL

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

Interventions

Arthroplasty PROCEDURE

All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision

Also known as: Knee arthroplasty, Hip arthroplasty, Knee aseptic revision arthroplasty, Hip arthroplaty revision

Standard; Vanco

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hopital Sacré-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Infections

Interventions

Arthroplasty; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Arthroplasty, Replacement; Prosthesis Implantation

Study Officials

• Benoit Benoit, MD

  CIUSSS du Nord de l'Île de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Because of the nature of the intervention, it is impossible for the surgeon to be blinded. However, postoperative infection will be diagnosed by an independent co-worker, not involved in the surgery. Patients will be blind as they will not be aware if they had intra-articular vancomycin powder or not
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon, principal investigator

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 22, 2020
• Study Start: July 5, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

CA (1)