IO Vancomycin Into the Medial Malleolus vs IV Administration in Revision TKA

Intraosseous (IO) Vancomycin Into the Medial Malleolus vs Intravenous (IV) Administration in Revision Total Knee Arthroplasty (TKA)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07283068

Enrollment

Registered

2025-12-15

Start date

2026-06-15

Completion date

2030-06-15

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Revision Total Knee Arthroplasty

Brief summary

Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during revision total knee arthroplasty

Interventions

DRUGIntraosseous Vancomycin

IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep of the leg and draping has occurred prior to skin incision (500mg in approximately 100mL NS). Injection will take place into the medial malleolus (within a pre-specified region) immediately prior to incision.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient is undergoing a revision total knee arthroplasty where in the opinion of the investigator, the patient's existing tibial component excludes the tibial tubercle as a valid intraosseous injection site. * Patient is able to understand the study design and intervention and gives informed consent to participate in the study. * Age \> 18 years.

Exclusion criteria

* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc). * Patient received or is scheduled to receive intravenous Vancomycin within 7 days prior to their planned revision procedure. * Any hardware, condition, or anatomic status that prevents the medial malleolus from being a viable intraosseous injection site. * Refusal to participate * Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.

Design outcomes

Primary

Measure	Time frame	Description
Level of Vancomycin	During the surgery	The study team will assess the level of vancomycin in the distal femur, proximal tibia, and systemic samples between the intravenous and intraosseous administration groups.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026