Regional Prophylactic Vancomycin With Restricted Tourniquet Time in Primary Total Knee Replacement

Summary

The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at obtaining adequate tissue levels of the antibiotic than the current standard dose which is given intravenously (IV) through a wrist vein. The use of intraosseous regional administration (IORA) of vancomycin requires the use of a tourniquet for the duration of the procedure. Many surgeons prefer to perform the surgery with tourniquet use minimised or without a tourniquet at all. The aim of this study is to evaluate whether IORA vancomycin can achieve effective tissue concentrations with tourniquet use minimised.

Timeline

Start

2018-09-24

Primary completion

2019-01-17

Completion

2019-01-17

Outcome

Met primary endpoint

paper were 5.2 μg/g in Group IV-Systemic and 33.1 μg/g in Group IORA (P < .001). PMID 35091036 ↗

paper Median bone concentrations taken just prior to cementation were 7.9 μg/g in Group IV-Systemic and 21.8 μg/g in Group IORA (P = .006). PMID 35091036 ↗

Publications

• Spangehl MJ, Clarke HD, Moore GA, Zhang M, Probst NE, Young SW. Higher Tissue Concentrations of Vancomycin Achieved With Low-Dose Intraosseous Injection Versus Intravenous Despite Limited Tourniquet Duration in Primary Total Knee Arthroplasty: A Randomized Trial. J Arthroplasty. 2022 May;37(5):857-863. doi: 10.1016/j.arth.2022.01.057. Epub 2022 Jan 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vancomycin	Other / unclassified	15 mg/kg	Intravenous
Subject	Vancomycin	Other / unclassified	500 mg	Intravenous

Indications