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Antibiotic

Antibiotics in Joint Replacement for Preventing Infections

N/A

Recruiting

Led By Benoit Benoit, MD

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Revision of an aseptic THA or TKA

Standard criteria for the implantation of primary total hip or knee replacement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether one dose of antibiotics is as effective as one dose of antibiotics plus intra-articular antibiotics for preventing infection in primary or revision THA/TKA patients.

Who is the study for?

Adults over 18 needing a new hip or knee joint (arthroplasty) due to osteoarthritis, bone death, arthritis, or previous joint replacement issues can join. They must be in good health for surgery and able to follow up for 2 years. People with skin diseases, infections, vancomycin allergies, or enrolled in other trials cannot participate.Check my eligibility

What is being tested?

This study is testing if adding intra-articular antibiotics to the usual single IV antibiotic dose lowers infection rates after hip/knee replacements. It's a randomized trial involving 1834 patients who will be observed for outcomes over about two years.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to vancomycin such as rash and redness at the injection site; however specific side effects related to this intervention are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having a revision of my hip or knee replacement due to non-infection reasons.

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I meet the requirements for a first-time hip or knee replacement.

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I have been diagnosed with a joint condition like OA, ON, arthritis, or issues with my hip/knee replacement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Communicable Diseases

Secondary outcome measures

Long-term infection rate

Primary vs revision

Risk factor

+1 more

Other outcome measures

EQ-5D-5L

The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VancoExperimental Treatment1 Intervention

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

Group II: StandardActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Arthroplasty

2013

Completed Phase 4

~30

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

12 Previous Clinical Trials

2,509 Total Patients Enrolled

Benoit Benoit, MDPrincipal InvestigatorCIUSSS du Nord de l'Île de Montreal

Media Library

Intra-articular Vancomycin Powder (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04399642 — N/A

Intra-articular Vancomycin Powder (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04399642 — N/A

Infections Research Study Groups: Vanco, Standard

Infections Clinical Trial 2023: Intra-articular Vancomycin Powder Highlights & Side Effects. Trial Name: NCT04399642 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can be enrolled in this research investigation?

"Affirmative. Clinicaltrials.gov attests that the study, which was first made public on July 5th 2019 is currently recruiting and searching for 1832 individuals from 1 trial site."

Answered by AI

Are there any active enrollment opportunities for this research endeavor?

"Clinicaltrials.gov shows that this medical study is actively recruiting participants, with the trial first posted on July 5th 2019 and most recently updated on July 12th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty

Benoit Benoit 2019. "Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04399642.