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NCT Number: NCT04399642

Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Sacré-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroplasty

Procedure

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

Other names: Knee arthroplasty, Hip arthroplasty, Knee aseptic revision arthroplasty, Hip arthroplaty revision

Primary outcomes

  1. Acute Infection rate

    Time frame: 3 months

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

Secondary outcomes

  1. Long-term infection rate

    Time frame: 2 years

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

  2. Risk factor

    Time frame: 2 years

    Infection rate in patients with risk factors depending on the antibiotic molecule that was given

  3. Primary vs revision

    Time frame: 2 years

    Infection rate in primary versus revisions surgery depending on the antibiotic molecule that was given

  4. Surgery time

    Time frame: 2 years

    Infection rate according to surgery time depending on the antibiotic molecule that was given

Other outcomes

  1. The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: baseline, 1 year

    Scale from 0 to 97. 97 indicate worse pain, stiffness, and functional limitations

  2. EQ-5D-5L

    Time frame: baseline, 1 year

    The descriptive system section of the EQ-5D questionnaire produces a 5-digit health state profile that represents the level of reported problems on each of the five dimensions of health

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty: a Prospective, Randomized Clinical Survey

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
May 22, 2020
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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