← Back to Search

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

Must not have

Active, local infection or systemic infection

Subjects unable to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

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

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any ongoing infections.

Select...

I am unable to give consent by myself.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Communicable Diseases

Secondary study objectives

Long-term infection rate

Primary vs revision

Risk factor

+1 more

Other study objectives

EQ-5D-5L

The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met