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

The Methodist Hospital Research Institute (TMHRI)

Status: Begins enrollment this month

Conditions: Revision Total Knee Arthroplasty

Treatments: Drug: Intraosseous Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT07283068

PRO00037463

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Intraosseous (IO) Vancomycin

Experimental group

Description:

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.

Treatment:

Drug: Intraosseous Vancomycin

Intravenous (IV) Vancomycin

No Intervention group

Description:

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).