Vancomycin in TKAs

NCT07282782 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 810594
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood

  Intraoperative

Study Arms (3)

Intravenous (IV) Vancomycin

NO INTERVENTION

Standard of care dose based on patient weight, organ function, and clinical factors at the discretion of the treating physician

Intraosseous (IO) Vancomycin

EXPERIMENTAL

500mg dose Vancomycin (in 100mL saline)

Drug: Vancomycin

Intraarticular (IA) Vancomycin

EXPERIMENTAL

500mg dose Vancomycin (in 30mL saline)

Drug: Vancomycin

Interventions

Vancomycin DRUG

Intraosseous or Intraarticular administration of Vancomycin

Intraarticular (IA) Vancomycin; Intraosseous (IO) Vancomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 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.

  PMID: 34053300 BACKGROUND

• 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 BACKGROUND

• 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 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.

  PMID: 37714404 BACKGROUND

• 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 BACKGROUND

• Matziolis G, Brodt S, Bohle S, Kirschberg J, Jacob B, Rohner E. Intraarticular vancomycin powder is effective in preventing infections following total hip and knee arthroplasty. Sci Rep. 2020 Aug 3;10(1):13053. doi: 10.1038/s41598-020-69958-0.

  PMID: 32747743 BACKGROUND

• R S, P S, Gh S, S B, M E, Ja B. Analysis of systemic serum vancomycin levels following intraarticular application in primary total joint arthroplasty. Arch Orthop Trauma Surg. 2024 Dec 18;145(1):60. doi: 10.1007/s00402-024-05688-6.

  PMID: 39694929 BACKGROUND

• Martin VT, Zhang Y, Wang Z, Liu QL, Yu B. A systematic review and meta-analysis comparing intrawound vancomycin powder and povidone iodine lavage in the prevention of periprosthetic joint infection of hip and knee arthroplasties. J Orthop Sci. 2024 Jan;29(1):165-176. doi: 10.1016/j.jos.2022.11.013. Epub 2022 Dec 2.

  PMID: 36470703 BACKGROUND

• Burns AWR, Chao T, Tsai N, Lynch JT, Smith PN. The use of intra-articular vancomycin is safe in primary hip and knee arthroplasty. J Orthop. 2023 Nov 4;46:161-163. doi: 10.1016/j.jor.2023.10.017. eCollection 2023 Dec.

  PMID: 37997601 BACKGROUND

• Martinez WF, Camacho Terceros L, Garbini F, Bochatey EJ, Lopreite FA. Complications of intraosseous administration of vancomycin in total hip arthroplasty. Rev Esp Cir Ortop Traumatol. 2025 Jul-Aug;69(4):340-346. doi: 10.1016/j.recot.2024.08.002. Epub 2024 Aug 8. English, Spanish.

  PMID: 39121941 BACKGROUND

• Park KJ, Wininger AE, Sullivan TC, Varghese B, Clyburn TA, Incavo SJ. Superior Clinical Results With Intraosseous Vancomycin in Primary Total Knee Arthroplasty. J Arthroplasty. 2025 Oct;40(10):2650-2654. doi: 10.1016/j.arth.2025.04.074. Epub 2025 May 5.

  PMID: 40334953 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.

  PMID: 40339929 BACKGROUND

MeSH Terms

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dominic Baun

CONTACT

858-534-8268; jbaun@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 15, 2025
• Study Start: June 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 3, 2026

Record last verified: 2025-10

Locations

US (1)