Revision Total Knee ArthroplastyNCT07283068
IO Vancomycin Into the Medial Malleolus vs IV Administration in Revision TKA
A study testing Intraosseous Vancomycin in people with Revision Total Knee Arthroplasty, run by The Methodist Hospital Research Institute.
Trial summary
Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during revision total knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision Total Knee Arthroplasty
- What is being tested?
- Intraosseous Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Jun 2030
- Phase
- Interventional
- 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
- Patient is undergoing a revision total knee arthroplasty where in the opinion of the investigator, the patient's existing tibial component excludes the tibial tubercle as a valid intraosseous injection site.
- Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
- Age > 18 years.
Who cannot join
- Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
- Patient received or is scheduled to receive intravenous Vancomycin within 7 days prior to their planned revision procedure.
- Any hardware, condition, or anatomic status that prevents the medial malleolus 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.
About this study
Official title: Intraosseous (IO) Vancomycin Into the Medial Malleolus vs Intravenous (IV) Administration in Revision Total Knee Arthroplasty (TKA)
Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during revision total knee arthroplasty
- Conditions
- Revision Total Knee Arthroplasty
- Being tested
- Intraosseous Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous VancomycinDrug
IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep of the leg and draping has occurred prior to skin incision (500mg in approximately 100mL NS). Injection will take place into the medial malleolus (within a pre-specified region) immediately prior to incision.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous (IO) Vancomycin | Experimental | IO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the operating room after sterile preparation of the leg and draping has occurred prior to skin incision (500mg in approximately 100mL NS). Injection will take place into the medial malleolus (within a pre-specified region) immediately prior to incision. Receives: Drug: Intraosseous Vancomycin |
| Intravenous (IV) Vancomycin | No intervention | Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for revision total knee arthroplasty patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight based at approximately 15mg/kg [12,13] generally 1000-1750mg in 500mL NS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Vancomycin
The study team will assess the level of vancomycin in the distal femur, proximal tibia, and systemic samples between the intravenous and intraosseous administration groups.
Measured: During the surgery
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 start15 Jun 2026 (estimated)
- Primary completion15 Feb 2030 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwan Park, MD, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283068
- Sponsor's protocol ID
- PRO00037463
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraosseous (IO) Vancomycin Into the Medial Malleolus vs Intravenous (IV) Administration in Revision Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT07283068
- Acronym / sponsor ID
- PRO00037463
- Conditions
- Revision Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Feb 2030 (estimated)
- Study completion
- 15 Jun 2030 (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.
Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during revision total knee arthroplasty
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraosseous (IO) Vancomycin | Experimental | Drug: Intraosseous VancomycinIO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the operating room after sterile preparation of the leg and draping has occurred prior to skin incision (500mg in approximately 100mL NS). Injection will take place into the medial malleolus (within a pre-specified region) immediately prior to incision. |
| Intravenous (IV) Vancomycin | No intervention | –Patients will receive the Houston Methodist Hospital orthopedic surgery standard of care pre-operative antibiotic regimen for revision total knee arthroplasty patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin) will be started in the pre-operative period approximately 1 hour prior to incision (vancomycin dose weight based at approximately 15mg/kg [12,13] generally 1000-1750mg in 500mL NS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is undergoing a revision total knee arthroplasty where in the opinion of the investigator, the patient's existing tibial component excludes the tibial tubercle as a valid intraosseous injection site.
- Patient is able to understand the study design and intervention and gives informed consent to participate in the study.
- Age > 18 years.
Key exclusion criteria (5 listed)
- Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
- Patient received or is scheduled to receive intravenous Vancomycin within 7 days prior to their planned revision procedure.
- Any hardware, condition, or anatomic status that prevents the medial malleolus 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.
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 VancomycinIO vancomycin is administered via an intraosseous cannulation device (Arrow EZ-IO; Teleflex, Morrisville, NC) in the OR after sterile prep of the leg and draping has occurred prior to skin incision (500mg in approximately 100mL NS). Injection will take place into the medial malleolus (within a pre-specified region) immediately prior to incision. | Drug | Intraosseous (IO) Vancomycin |
Primary outcome
Level of Vancomycin
Time frame: During the surgery
The study team will assess the level of vancomycin in the distal femur, proximal tibia, and systemic samples between the intravenous and intraosseous administration groups.
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 20 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intraosseous Vancomycin in people with Revision Total Knee Arthroplasty, run by The Methodist Hospital Research Institute.
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 5 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 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Vancomycin (time frame: During the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.