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The goal of this clinical trial is to compare the efficacy of intravenous (IV) and intraosseous (IO) antibiotic administration techniques during primary total knee arthroplasty (TKA) in adults undergoing a TKA procedure at Houston Methodist Hospital. The main questions it aims to answer are:
Does IO administration of vancomycin and cefazolin protect against perioperative exposure risks? Is there a difference in post-operative complication rates between IV and IO administration of these drugs?
Participants will be randomized to receive either the standard of care IV administration of Vancomycin and Cefazolin, or the IO administration of Vancomycin and Cefazolin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraosseous Administration of Vancomycin and Cefazolin | Experimental | Intraosseous vancomycin plus cefazolin 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 and after the tourniquet has been inflated. The injection will take place into the tibial tubercle, which is a known safe IO injection site. The IO injection will include 500mg of vancomycin and a 1g dose of cefazolin, previously used in prior IO studies of cefazolin. |
|
| Standard IV Administration of Vancomycin and Cefazolin | Active Comparator | Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for primary total knee arthroplasty patients. This includes IV antibiotics cefazolin will be started in the pre-operative period approximately 1 hour prior to incision. The cefazolin dose is generally 2g if patient is under 120kg, and 3g is the patient is above 120kg in line with guidelines. Vancomycin IV administration will be dosing will be weight-based at approximately 15mg/kg generally 1000-1750mg in 500mL NS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IO Administration of Cefazolin | Drug | Intraosseous injection of cefazolin to guard against infection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Postoperative Infections | Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any infections. | 30 days postop and 90 days postop |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Wound Complications | Participants charts will be reviewed at 30 days postop and 90 days postop to determine if there were any wound complications. | 30 days postop and 90 days postop |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Sullivan | Contact | 346-238-1603 | tsullivan@houstonmethodist.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21652786 | Background | Nunn MO, Corallo CE, Aubron C, Poole S, Dooley MJ, Cheng AC. Vancomycin dosing: assessment of time to therapeutic concentration and predictive accuracy of pharmacokinetic modeling software. Ann Pharmacother. 2011 Jun;45(6):757-63. doi: 10.1345/aph.1P634. Epub 2011 Jun 7. | |
| 33468344 | Background | Klasan A, Patel CK, Young SW. Intraosseous Regional Administration of Vancomycin in Primary Total Knee Arthroplasty Does Not Increase the Risk of Vancomycin-Associated Complications. J Arthroplasty. 2021 May;36(5):1633-1637. doi: 10.1016/j.arth.2020.12.034. Epub 2020 Dec 26. |
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| IO Administration of Vancomycin | Drug | Intraosseous injection of vancomycin to guard against infection. |
|
| IV Administration of Cefazolin | Drug | Intravenous dose of cefazolin to guard against infection. |
|
| IV Administration of Vancomycin | Drug | Intravenous dose of vancomycin to guard against infection. |
|
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| 34053300 | Background | Park KJ, Chapleau J, Sullivan TC, Clyburn TA, Incavo SJ. 2021 Chitranjan S. Ranawat Award: Intraosseous vancomycin reduces periprosthetic joint infection in primary total knee arthroplasty at 90-day follow-up. Bone Joint J. 2021 Jun;103-B(6 Supple A):13-17. doi: 10.1302/0301-620X.103B6.BJJ-2020-2401.R1. |
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| 23327981 | Background | Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available. |
| 12720556 | Background | Sivagnanam S, Deleu D. Red man syndrome. Crit Care. 2003 Apr;7(2):119-20. doi: 10.1186/cc1871. Epub 2002 Dec 23. |
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| 37851875 | Background | Peel TN, Astbury S, Cheng AC, Paterson DL, Buising KL, Spelman T, Tran-Duy A, Adie S, Boyce G, McDougall C, Molnar R, Mulford J, Rehfisch P, Solomon M, Crawford R, Harris-Brown T, Roney J, Wisniewski J, de Steiger R; ASAP Trial Group. Trial of Vancomycin and Cefazolin as Surgical Prophylaxis in Arthroplasty. N Engl J Med. 2023 Oct 19;389(16):1488-1498. doi: 10.1056/NEJMoa2301401. |
| 23645338 | Background | Liu C, Kakis A, Nichols A, Ries MD, Vail TP, Bozic KJ. Targeted use of vancomycin as perioperative prophylaxis reduces periprosthetic joint infection in revision TKA. Clin Orthop Relat Res. 2014 Jan;472(1):227-31. doi: 10.1007/s11999-013-3029-0. |
| 29656981 | Background | Burger JR, Hansen BJ, Leary EV, Aggarwal A, Keeney JA. Dual-Agent Antibiotic Prophylaxis Using a Single Preoperative Vancomycin Dose Effectively Reduces Prosthetic Joint Infection Rates With Minimal Renal Toxicity Risk. J Arthroplasty. 2018 Jul;33(7S):S213-S218. doi: 10.1016/j.arth.2018.03.009. Epub 2018 Mar 14. |
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| 35051610 | Background | Spangehl M. Preoperative Prophylactic Antibiotics in Total Hip and Knee Arthroplasty: What, When, and How. J Arthroplasty. 2022 Aug;37(8):1432-1434. doi: 10.1016/j.arth.2022.01.019. Epub 2022 Jan 17. |
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| 36294449 | Background | Rodriguez-Merchan EC, Delgado-Martinez AD. Risk Factors for Periprosthetic Joint Infection after Primary Total Knee Arthroplasty. J Clin Med. 2022 Oct 18;11(20):6128. doi: 10.3390/jcm11206128. |
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