Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)

Официальное название

Intraosseous Vancomycin and Cefazolin vs Intravenous Administration in Primary Total Knee Arthroplasty

Обзор

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.

Вмешательства

• Препарат IO Administration of Cefazolin
  Intraosseous injection of cefazolin to guard against infection.
• Препарат IO Administration of Vancomycin
  Intraosseous injection of vancomycin to guard against infection.
• Препарат IV Administration of Cefazolin
  Intravenous dose of cefazolin to guard against infection.
• Препарат IV Administration of Vancomycin
  Intravenous dose of vancomycin to guard against infection.

Первичные конечные точки

• Rate of Postoperative Infections [Срок оценки: 30 days postop and 90 days postop]

Вторичные конечные точки (1)

• Postoperative Wound Complications [Срок оценки: 30 days postop and 90 days postop]

Критерии участия

Критерии включения

• Patient is scheduled to undergo an elective primary total knee arthroplasty.
• Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
• Patient is 18 years or older.

Критерии исключения

• Contraindication to receiving vancomycin or cefazolin.
• Body mass index (BMI) > 40.
• Uncontrolled Diabetes (defined as A1c > 7.5%).
• Patient received or is scheduled to receive IV vancomycin or cefazolin within 7 days prior to their planned procedure.
• Any hardware, condition, or anatomic status that prevents the tibial tubercle 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Houston Methodist Hospital — Houston

Публикации

• 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. PMID 21652786
• 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. PMID 33468344
• Parkinson B, McEwen P, Wilkinson M, Hazratwala K, Hellman J, Kan H, McLean A, Panwar Y, Doma K, Grant A. Intraosseous Regional Prophylactic Antibiotics Decrease the Risk of Prosthetic Joint Infection in Primary TKA: A Multicenter Study. Clin Orthop Relat Res. 2021 Nov 1;479(11):2504-2512. doi: 10.1097/CORR.0000000000001919. PMID 34397615
• 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. PMID 34053300
• Chin SJ, Moore GA, Zhang M, Clarke HD, Spangehl MJ, Young SW. The AAHKS Clinical Research Award: Intraosseous Regional Prophylaxis Provides Higher Tissue Concentrations in High BMI Patients in Total Knee Arthroplasty: A Randomized Trial. J Arthroplasty. 2018 Jul;33(7S):S13-S18. doi: 10.1016/j.arth.2018.03.013. Epub 2018 Mar 15. PMID 29655497
• Young SW, Zhang M, Freeman JT, Mutu-Grigg J, Pavlou P, Moore GA. The Mark Coventry Award: Higher tissue concentrations of vancomycin with low-dose intraosseous regional versus systemic prophylaxis in TKA: a randomized trial. Clin Orthop Relat Res. 2014 Jan;472(1):57-65. doi: 10.1007/s11999-013-3038-z. PMID 23666589
• Harper KD, Lambert BS, O'Dowd J, Sullivan T, Incavo SJ. Clinical outcome evaluation of intraosseous vancomycin in total knee arthroplasty. Arthroplast Today. 2020 Mar 7;6(2):220-223. doi: 10.1016/j.artd.2020.02.001. eCollection 2020 Jun. PMID 32577466
• Young SW, Zhang M, Freeman JT, Vince KG, Coleman B. Higher cefazolin concentrations with intraosseous regional prophylaxis in TKA. Clin Orthop Relat Res. 2013 Jan;471(1):244-9. doi: 10.1007/s11999-012-2469-2. PMID 22773397

Идентификаторы

NCT: NCT06640491 · PRO00038477

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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