Intraosseous Vancomycin for Total Knee Replacement

(IO Vanco Trial)

DB
Overseen ByDominic Baun
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Eligible participants will receive preoperative intraosseous vancomycin (500 mg in 100 mL saline) as part of standard perioperative infection prophylaxis. The study is open-label due to the nature of the intervention. Blood samples will be collected at predefined time points intraoperatively to measure serum vancomycin concentrations. Patients will be randomized to either a tourniquet or no tourniquet for these blood draws.

Are You a Good Fit for This Trial?

This trial is for adults over 18 having their first knee replacement surgery at UC San Diego who can give consent and are suitable to receive vancomycin through the bone.

Inclusion Criteria

I am over 18 and receiving treatment at UC San Diego.
I am having my first total knee replacement on one knee.
3. Is able to provide consent
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive preoperative intraosseous vancomycin as part of standard perioperative infection prophylaxis

1 day
1 visit (in-person)

Intraoperative Monitoring

Blood samples are collected at predefined time points intraoperatively to measure serum vancomycin concentrations

During surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Vancomycin

Trial Overview

The study tests giving vancomycin (an antibiotic) directly into the bone before knee replacement surgery, then measures how much of it gets into the blood. Patients are randomly assigned to have a tourniquet or not during these measurements.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Tourniquet IO VancomycinExperimental Treatment1 Intervention
Group II: Non tourniquet IO VancomycinExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+