Total Knee ArthroplastyPhase 4NCT07282782
Vancomycin in TKAs
A Phase 4 study testing Vancomycin in people with Total Knee Arthroplasty, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
San Diego, California, 92093
Dominic Baun, MS, 858-534-8268, jbaun@health.ucsd.edu
Scott Ball, MD
About this study
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
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
- Being tested
- Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VancomycinDrug
Intraosseous or Intraarticular administration of Vancomycin
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Vancomycin |
| Intraarticular (IA) Vancomycin | Experimental | 500mg dose Vancomycin (in 30mL saline) Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start10 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Ball, MD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282782
- Sponsor's protocol ID
- 810594
- Status last verified
- Oct 2025
- First submitted
- 5 Dec 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 33422392Xu 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.
PubMed 37655835Spangehl 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.
PubMed 35091036Park 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.
PubMed 34053300Miltenberg 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.
PubMed 36280158Shao 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.
PubMed 37784182Hu 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.
PubMed 37714404Burns 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.
PubMed 38419970Matziolis 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.
PubMed 32747743R 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.
PubMed 39694929Martin 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.
PubMed 36470703Burns 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.
PubMed 37997601Martinez 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.
PubMed 39121941Park 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.
PubMed 40334953McNamara 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(S19):S28-S32. doi: 10.1016/j.arth.2025.04.060. Epub 2025 May 6.
PubMed 40339929
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07282782
- Acronym / sponsor ID
- 810594
- Conditions
- Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Vancomycin500mg dose Vancomycin (in 100mL saline) |
| Intraarticular (IA) Vancomycin | Experimental | Drug: Vancomycin500mg dose Vancomycin (in 30mL saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VancomycinIntraosseous or Intraarticular administration of Vancomycin | Drug | Intraarticular (IA) Vancomycin, Intraosseous (IO) Vancomycin |
Primary outcome
Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 33422392Premkumar 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.
- Background: PubMed 37655835Xu 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.
- Background: PubMed 35091036Spangehl 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.
- Background: PubMed 34053300Park 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.
- Background: PubMed 36280158Miltenberg 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.
- Background: PubMed 37784182Shao 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.
- Background: PubMed 37714404Hu 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.
- Background: PubMed 38419970Burns 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.
- Background: PubMed 32747743Matziolis 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.
- Background: PubMed 39694929R 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.
- Background: PubMed 36470703Martin 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.
- Background: PubMed 37997601Burns 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.
Related trials for Total Knee Arthroplasty
Active, not recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingObservational study
Agreement Between Patient-Reported Pain, Observer-Rated Pain Behavior, and Analgesic Request After Total Knee Arthroplasty
Postoperative Pain After Total Knee Arthroplasty
Enrolling by invitationObservational study
Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty
Total Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vancomycin in people with Total Knee Arthroplasty, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominic Baun (858-534-8268, jbaun@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of vancomycin in bone, synovial tissue, subcutaneous fat and serum blood (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07282782, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.