InfectionNCT04399642
Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty
A study testing Arthroplasty in people with Infection, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Arthroplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,832 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jul 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty: a Prospective, Randomized Clinical Survey
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.
- Conditions
- Infection
- Being tested
- Arthroplasty
- Keywords
- vancomycine, hip arthroplasty, knee arthroplasty, hip revision arthroplasty, knee revision arthroplasty
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthroplastyProcedure or surgery
Also called Knee arthroplasty, Hip arthroplasty, Knee aseptic revision arthroplasty, Hip arthroplaty revision
All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Patients receiving single dose of IV cefazolin (2 grams if < 120kg; 3 grams if >120kg) 10-60 minutes before incision Receives: 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 Receives: Procedure: Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Infection rate
Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given
Measured: 3 months
Secondary outcomes (4)
Long-term infection rate
Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given
Measured: 2 years
Risk factor
Infection rate in patients with risk factors depending on the antibiotic molecule that was given
Measured: 2 years
Primary vs revision
Infection rate in primary versus revisions surgery depending on the antibiotic molecule that was given
Measured: 2 years
Surgery time
Infection rate according to surgery time depending on the antibiotic molecule that was given
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start5 Jul 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,832 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benoit Benoit, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Benoit Benoit, MD, Principal investigator, CIUSSS du Nord de l'Île de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399642
- Sponsor's protocol ID
- Single-Dose
- Status last verified
- Sep 2025
- First submitted
- 15 May 2020
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty: a Prospective, Randomized Clinical Survey
- ClinicalTrials.gov ID
- NCT04399642
- Acronym / sponsor ID
- Single-Dose
- Conditions
- Infection
- Keywords
- vancomycine, hip arthroplasty, knee arthroplasty, hip revision arthroplasty, knee revision arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,832 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Procedure: ArthroplastyPatients receiving single dose of IV cefazolin (2 grams if < 120kg; 3 grams if >120kg) 10-60 minutes before incision |
| Vanco | Experimental | Procedure: ArthroplastyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArthroplastyAlso: Knee arthroplasty, Hip arthroplasty, Knee aseptic revision arthroplasty, Hip arthroplaty revisionAll patients include in the study will undergo a lowerlimb arthroplasty, primary or revision | Procedure or surgery | Standard, Vanco |
Primary outcome
Acute Infection rate
Time frame: 3 months
Infection rate after after lowerlimb arthroplasty depending on the antibiotic molecule that was given
4 secondary outcomes
Long-term infection rate
Time frame: 2 years
Risk factor
Time frame: 2 years
Primary vs revision
Time frame: 2 years
Surgery time
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Benoit, MD principal investigator
CIUSSS du Nord de l'Île de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroplasty in people with Infection, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Infection rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.