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Active, not recruitingNCT04399642Updated Sep 11, 2025

Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

An interventional study of Arthroplasty in Infection, sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
  • Registered 10 months after the study started (first participant enrolled Jul 2019, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
1,832
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infection

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Keywords

  • vancomycine
  • hip arthroplasty
  • knee arthroplasty
  • hip revision arthroplasty
  • knee revision arthroplasty
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 1,832 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal is the lead sponsor of 31 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
1,832 participants (estimated)

Study arms

  • Active comparator
    Standard

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

    Procedure: Arthroplasty

  • Experimental
    Vanco

    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

  • ProcedureArthroplasty

    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

06

What researchers measure

Primary outcomes

  1. Acute Infection rate

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

    Time frame: 3 months

Secondary outcomes

  1. Long-term infection rate

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

    Time frame: 2 years

  2. Risk factor

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

    Time frame: 2 years

  3. Primary vs revision

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

    Time frame: 2 years

  4. Surgery time

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

    Time frame: 2 years

Other outcomes

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

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

    Time frame: baseline, 1 year

  2. EQ-5D-5L

    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

    Time frame: baseline, 1 year

07

Study locations

1 site
  • Hopital Sacré-Coeur de Montreal
    Montreal, Quebec H4J 1C5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04399642
Lead sponsor
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Responsible party
Benoit Benoit (Orthopaedic surgeon, principal investigator, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal) — Principal investigator
First posted
May 22, 2020
Start date
Jul 5, 2019
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 11, 2025

Study contacts

Benoit Benoit, MD
principal investigator · CIUSSS du Nord de l'Île de Montreal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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