drugset / Trial / NCT07633418
IO Vancomycin Administration in TKA
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Eligible participants will receive preoperative intraosseous vancomycin (500 mg in 100 mL saline) as part of standard perioperative infection prophylaxis. The study is open-label due to the nature of the intervention. Blood samples will be collected at predefined time points intraoperatively to measure serum vancomycin concentrations. Patients will be randomized to either a tourniquet or no tourniquet for these blood draws.
Timeline
- Start
- 2026-06-01
- Primary completion
- 2027-04-29
- Completion
- 2029-04-29
Publications
- Background Olsen Kipp J, Hanberg P, Slater J, Moller Nielsen L, Storgaard Jakobsen S, Stilling M, Bue M. Vancomycin bone and tissue concentrations following tibial intraosseous administration - evaluated in a porcine model. J Bone Jt Infect. 2021 Feb 12;6(4):99-106. doi: 10.5194/jbji-6-99-2021. eCollection 2021.
- Background Hu M, Zhang Y, Yang X, Wang Y, Xu H, Xiang S. Intraarticular vancomycin decreased the risk of acute postoperative periprosthetic joint infection without increasing complication in primary total joint arthroplasty-a prospective study. Int J Infect Dis. 2023 Nov;136:64-69. doi: 10.1016/j.ijid.2023.09.004. Epub 2023 Sep 14.
- Background McNamara CA, Wininger AE, Sullivan TC, Brown TS, Clyburn TA, Incavo SJ, Park KJ. The AAHKS Best Podium Presentation Research Award: Intraosseous Vancomycin Reduces the Rate of Periprosthetic Joint Infection Following Aseptic Revision Total Knee Arthroplasty. J Arthroplasty. 2025 Sep;40(9S1):S28-S32. doi: 10.1016/j.arth.2025.04.060. Epub 2025 May 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vancomycin | Other / unclassified | 500 mg | Other |
Indications
No indication recorded.