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

NCT07283068 | Not Yet Recruiting

• 1 other identifier: PRO00037463
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Revision Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Level of Vancomycin

  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.

  During the surgery

Study Arms (2)

Intraosseous (IO) Vancomycin

EXPERIMENTAL

IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the operating room after sterile preparation 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.

Drug: Intraosseous Vancomycin

Intravenous (IV) Vancomycin

NO INTERVENTION

Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for revision total knee arthroplasty patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight based at approximately 15mg/kg \[12,13\] generally 1000-1750mg in 500mL NS).

Interventions

Intraosseous Vancomycin DRUG

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.

Intraosseous (IO) Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): February 15, 2030
• Study Completion (Estimated): June 15, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share