Vancomycin in TKAs

May 31, 2026 updated by: Scott Ball, MD, University of California, San Diego

A Prospective, Randomized Parallel Group Study of the Efficacy of Vancomycin Administered Through Intraarticular Injection Versus Intraosseous Injection Versus Intravenous Infusion in Patients Undergoing Total Knee Arthroplasty

Periprosthetic joint infection (PJI) is a national health crisis and leads to very poor outcomes for patients undergoing elective joint replacement. Within the realm of elective total knee arthroplasty (TKA), various methods of infection prophylaxis are in place. These include sterile precautions, would/tissue handling, and antibiotic prophylaxis. With respect to the latter, various approaches have been utilized including intravenous and intraosseous administration of vancomycin, preoperatively. Intraosseous administration does require another wound and a specific device to administer. The investigators proposed that intraarticular injection of vancomycin is non-inferior to intraosseous administration, thus reducing wounds, time, and cost.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
        • Recruiting
        • University of California, San Diego
        • Principal Investigator:
          • Scott Ball, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Any patient over the age of 18 years of age receiving treatment at UC San Diego Health
  • Undergoing primary unilateral TKA
  • Ability to provide consent

Exclusion Criteria:

  • previous surgery on the knee (with the exception of arthroscopy)
  • BMI > 35
  • contraindication to receiving vancomycin, cefepime or cefazolin (ie, allergy, etc)
  • diabetics with A1c>7.5% (unless controlled fructosamine)
  • immunocompromised or immunosuppressed patients (HIV, Hepatitis C, end stage renal disease (ESRD), post transplant, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating meducations)
  • no history of active infections
  • no history of chronic kidney disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Intravenous (IV) Vancomycin
Standard of care dose based on patient weight, organ function, and clinical factors at the discretion of the treating physician
Experimental: Intraosseous (IO) Vancomycin
500mg dose Vancomycin (in 100mL saline)
Drug: Vancomycin
Intraosseous or Intraarticular administration of Vancomycin
Experimental: Intraarticular (IA) Vancomycin
500mg dose Vancomycin (in 30mL saline)
Drug: Vancomycin
Intraosseous or Intraarticular administration of Vancomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood
Time Frame: Intraoperative
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 810594

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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