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

NCT ID: NCT07283068

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-15
• Study Completion Date: 2030-06-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intraosseous (IO) Vancomycin

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.

Group Type: EXPERIMENTAL

Intraosseous Vancomycin

Intervention Type: 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.

Intravenous (IV) Vancomycin

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intraosseous 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Kwan Park, MD

Orthopedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PRO00037463

Identifier Type: -

Identifier Source: org_study_id