Recruiting NCT06640491
Intraosseous (IO) Cefazolin and Vancomycin in Primary Total Knee Arthroplasty (TKA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IO Administration of Cefazolin, IO Administration of Vancomycin, IV Administration of Cefazolin, IV Administration of Vancomycin.
- Who it may be relevant to
- Registry conditions: Total Knee Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intraosseous Vancomycin and Cefazolin vs Intravenous Administration in Primary Total Knee Arthroplasty
Overview
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.
Interventions
- Drug IO Administration of Cefazolin
Intraosseous injection of cefazolin to guard against infection. - Drug IO Administration of Vancomycin
Intraosseous injection of vancomycin to guard against infection. - Drug IV Administration of Cefazolin
Intravenous dose of cefazolin to guard against infection. - Drug IV Administration of Vancomycin
Intravenous dose of vancomycin to guard against infection.
Primary outcome measures
- Rate of Postoperative Infections [Time frame: 30 days postop and 90 days postop]
Secondary outcome measures (1)
- Postoperative Wound Complications [Time frame: 30 days postop and 90 days postop]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Houston Methodist Hospital — Houston
Publications
- 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
Identifiers
NCT: NCT06640491 · PRO00038477