Menu
Recruiting NCT07282782

Vancomycin in TKAs

Phase IV Interventional Total Knee Arthroplasty

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: 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

A Prospective, Randomized Parallel Group Study of the Efficacy of Vancomycin Administered Through Intraarticular Injection Versus Intraosseous Injection Versus Intravenous Infusion in Patients Undergoing Total Knee Arthroplasty

Overview

Periprosthetic joint infection (PJI) is a national health crisis and leads to very poor outcomes for patients undergoing elective joint replacement. Within the realm of elective total knee arthroplasty (TKA), various methods of infection prophylaxis are in place. These include sterile precautions, would/tissue handling, and antibiotic prophylaxis. With respect to the latter, various approaches have been utilized including intravenous and intraosseous administration of vancomycin, preoperatively. Intraosseous administration does require another wound and a specific device to administer. The investigators proposed that intraarticular injection of vancomycin is non-inferior to intraosseous administration, thus reducing wounds, time, and cost.

Interventions

  • Drug Vancomycin
    Intraosseous or Intraarticular administration of Vancomycin

Primary outcome measures

  • Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood [Time frame: Intraoperative]

Eligibility criteria

Inclusion criteria

  • Any patient over the age of 18 years of age receiving treatment at UC San Diego Health
  • Undergoing primary unilateral TKA
  • Ability to provide consent

Exclusion criteria

  • previous surgery on the knee (with the exception of arthroscopy)
  • BMI > 35
  • contraindication to receiving vancomycin, cefepime or cefazolin (ie, allergy, etc)
  • diabetics with A1c>7.5% (unless controlled fructosamine)
  • immunocompromised or immunosuppressed patients (HIV, Hepatitis C, end stage renal disease (ESRD), post transplant, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating meducations)
  • no history of active infections
  • no history of chronic kidney disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of California, San Diego — San Diego

Publications

  • Premkumar A, Kolin DA, Farley KX, Wilson JM, McLawhorn AS, Cross MB, Sculco PK. Projected Economic Burden of Periprosthetic Joint Infection of the Hip and Knee in the United States. J Arthroplasty. 2021 May;36(5):1484-1489.e3. doi: 10.1016/j.arth.2020.12.005. Epub 2020 Dec 9. PMID 33422392
  • Xu Y, Huang TB, Schuetz MA, Choong PFM. Mortality, patient-reported outcome measures, and the health economic burden of prosthetic joint infection. EFORT Open Rev. 2023 Sep 1;8(9):690-697. doi: 10.1530/EOR-23-0078. PMID 37655835
  • 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. PMID 35091036
  • 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
  • Miltenberg B, Ludwick L, Masood R, Menendez ME, Moverman MA, Pagani NR, Puzzitiello RN, Smith EL. Intraosseous Regional Administration of Antibiotic Prophylaxis for Total Knee Arthroplasty: A Systematic Review. J Arthroplasty. 2023 Apr;38(4):769-774. doi: 10.1016/j.arth.2022.10.023. Epub 2022 Oct 22. PMID 36280158
  • Shao H, Zhou Y. Management of soft tissues in patients with periprosthetic joint infection. Arthroplasty. 2023 Oct 3;5(1):52. doi: 10.1186/s42836-023-00205-3. PMID 37784182
  • 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. PMID 37714404
  • Burns AWR, Smith P, Lynch J. Intra-articular Vancomycin Reduces Prosthetic Infection in Primary Hip and Knee Arthroplasty. Arthroplast Today. 2024 Feb 24;26:101333. doi: 10.1016/j.artd.2024.101333. eCollection 2024 Apr. PMID 38419970

Identifiers

NCT: NCT07282782 · 810594

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗