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Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

C

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

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

Trial contacts and locations

1

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Central trial contact

Benoit Benoit, MD; Karine Tardif

Data sourced from clinicaltrials.gov

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