Total Knee ArthroplastyPhase 4IO VancoNCT07633418
IO Vancomycin Administration in TKA
A Phase 4 study testing Intraosseous Vamcomycin Administration in people with Total Knee Arthroplasty, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Intraosseous Vamcomycin Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 29 Apr 2029
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a patient over the age of 18 receiving treatment at UC San Diego
- Is undergoing primary unilateral total knee arthroplasty
- Is able to provide consent
- Is candidate for IO administration of Vancomycin
Who cannot join
- Has had a previous surgery on the knee of interest (with the exception of arthroscopy)
- Has a BMI >35
- Has a contraindication to receiving vancomycin, cefepime, or cefazolin (i.e. allergy)
- Has diabetes with A1c >7.5% (unless with controlled fructosamine)
- Is immunocompromised/immunosuppressed (i.e. due to HIV, hepatitis C, end-stage renal disease, post-transplant status, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating medications)
- Has a history of active infection
Show all 9Show fewer
- Inability to provide consent
- Prisoner
- Pregnant women
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
UC San Diego
San Diego, California, 92093
Dominic Baun, 858-534-8268, jbaun@health.ucsd.edu
Scott Ball, MD
About this study
Official title: Systemic Vancomycin Levels in Intraosseous Administration During Total Knee Arthroplasty
This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Eligible participants will receive preoperative intraosseous vancomycin (500 mg in 100 mL saline) as part of standard perioperative infection prophylaxis. The study is open-label due to the nature of the intervention. Blood samples will be collected at predefined time points intraoperatively to measure serum vancomycin concentrations. Patients will be randomized to either a tourniquet or no tourniquet for these blood draws.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Intraosseous Vamcomycin Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous Vamcomycin AdministrationDrug
IO Vancomycin Administration in TKA
| Study group | Role | What they receive |
|---|---|---|
| Non tourniquet IO Vancomycin | Other | TKA IO Vancomycin administration with no tourniquet. Receives: Drug: Intraosseous Vamcomycin Administration |
| Tourniquet IO Vancomycin | Other | TKA IO Vancomycin Administration with tourniquet Receives: Drug: Intraosseous Vamcomycin Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Vancomycin Levels
Serum Vancomycin Levels following IO Vancomycin administration
Measured: From administration up to 30 minutes post-administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion29 Apr 2027 (estimated)
- Study completion29 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- NCT07633418
- Sponsor's protocol ID
- 804904
- Acronym
- IO Vanco
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olsen Kipp J, Hanberg P, Slater J, Moller Nielsen L, Storgaard Jakobsen S, Stilling M, Bue M. Vancomycin bone and tissue concentrations following tibial intraosseous administration - evaluated in a porcine model. J Bone Jt Infect. 2021 Feb 12;6(4):99-106. doi: 10.5194/jbji-6-99-2021. eCollection 2021.
PubMed 34084697Hu 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 37714404McNamara 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Vancomycin Levels in Intraosseous Administration During Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07633418
- Acronym / sponsor ID
- IO Vanco / 804904
- Conditions
- Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 29 Apr 2027 (estimated)
- Study completion
- 29 Apr 2029 (estimated)
- First posted
- 8 Jun 2026 (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.
This is a prospective, single-center, open-label study evaluating systemic vancomycin levels following preoperative intraosseous administration in patients undergoing primary unilateral total knee arthroplasty. Eligible participants will receive preoperative intraosseous vancomycin (500 mg in 100 mL saline) as part of standard perioperative infection prophylaxis. The study is open-label due to the nature of the intervention. Blood samples will be collected at predefined time points intraoperatively to measure serum vancomycin concentrations. Patients will be randomized to either a tourniquet or no tourniquet for these blood draws.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non tourniquet IO Vancomycin | Other | Drug: Intraosseous Vamcomycin AdministrationTKA IO Vancomycin administration with no tourniquet. |
| Tourniquet IO Vancomycin | Other | Drug: Intraosseous Vamcomycin AdministrationTKA IO Vancomycin Administration with tourniquet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is a patient over the age of 18 receiving treatment at UC San Diego
- Is undergoing primary unilateral total knee arthroplasty
- Is able to provide consent
- Is candidate for IO administration of Vancomycin
Key exclusion criteria (9 listed)
- Has had a previous surgery on the knee of interest (with the exception of arthroscopy)
- Has a BMI >35
- Has a contraindication to receiving vancomycin, cefepime, or cefazolin (i.e. allergy)
- Has diabetes with A1c >7.5% (unless with controlled fructosamine)
- Is immunocompromised/immunosuppressed (i.e. due to HIV, hepatitis C, end-stage renal disease, post-transplant status, chemotherapy or radiation therapy within 6 months of surgery, immunomodulating medications)
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 |
|---|---|---|
| Intraosseous Vamcomycin AdministrationIO Vancomycin Administration in TKA | Drug | Non tourniquet IO Vancomycin, Tourniquet IO Vancomycin |
Primary outcome
Serum Vancomycin Levels
Time frame: From administration up to 30 minutes post-administration.
Serum Vancomycin Levels following IO Vancomycin administration
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 8 Jun 2026.
- Background: PubMed 34084697Olsen Kipp J, Hanberg P, Slater J, Moller Nielsen L, Storgaard Jakobsen S, Stilling M, Bue M. Vancomycin bone and tissue concentrations following tibial intraosseous administration - evaluated in a porcine model. J Bone Jt Infect. 2021 Feb 12;6(4):99-106. doi: 10.5194/jbji-6-99-2021. eCollection 2021.
- 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 40339929McNamara 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.
- Individual participant dataSharing planned: No
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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 Intraosseous Vamcomycin Administration 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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 8 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?
Serum Vancomycin Levels (time frame: From administration up to 30 minutes post-administration.). 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 NCT07633418, which also lists 3 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 8 Jun 2026.