InfectionsPhase 4IOTAANCT06384651
Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
A Phase 4 study testing Intraosseous Vancomycin Injection and Intravenous Vancomycin in people with Infections and Ankle Arthritis, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA). Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Ankle Arthritis
- What is being tested?
- Intraosseous Vancomycin Injection and Intravenous Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to Dec 2027
- 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
- Patient is undergoing total ankle arthroplasty.
- Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study
- Age Range >18
Who cannot join
- Previous lower extremity surgery that in the opinion of the principal investigator or qualified research personnel precludes the participant from safely participating on the study.
- BMI > 40.
- Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
- Inability to administer the IO infusion.
- Patient refusal to participate.
- Uncontrolled Diabetes Mellitus type 1 or 2, defined as Hemoglobin A1C >7.5.
- Immunocompromised or immunosuppressed patients (HIV, Hep C, end stage renal disease, dialysis, transplant, chemo/radiation treatment in last 6 months, medications).
- Vulnerable populations
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
Houston Methodist Hospital
Houston, Texas, 77030
Thomas C Sullivan, BS, 346-238-1603, tsullivan@houstonmethodist.org
Jason S Ahuero, MD
About this study
The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).
Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.
Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.
- Conditions
- Infections, Ankle Arthritis
- Being tested
- Intraosseous Vancomycin Injection, Intravenous Vancomycin
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous Vancomycin InjectionDrug
- IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
- IO Injection will take place into the medial malleolus.
Intravenous VancomycinDrug
- Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS))
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Vancomycin | Active comparator | Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS)) Receives: Drug: Intravenous Vancomycin |
| Intraosseous Vancomycin | Experimental | IV antibiotics per physician's standard of care: Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be given preoperatively in this group.
IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS).
IO Injection will take place into the medial malleolus. Receives: Drug: Intraosseous Vancomycin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Sample Vancomycin Tissue Concentration - Start of Case
Measured: perioperatively
Systemic Sample Vancomycin Tissue Concentration - End of Case
Measured: perioperatively
Capsule or Synovium Sample Vancomycin Tissue Concentration
Measured: immediately after the procedure
Distal Tibia Sample Vancomycin Tissue Concentration
Measured: immediately after the procedure
Talar Bone Sample Vancomycin Tissue Concentration
Measured: immediately after the procedure
Secondary outcomes (1)
90 day post-operative wound complication and infection rates
Measured: 90 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start3 Dec 2024
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason S. Ahuero, The Methodist Hospital Research Institute
- Investigators
- Jason S Ahuero, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384651
- Sponsor's protocol ID
- PRO00037789
- Acronym
- IOTAA
- Status last verified
- Jan 2025
- First submitted
- 2 Apr 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty
- ClinicalTrials.gov ID
- NCT06384651
- Acronym / sponsor ID
- IOTAA / PRO00037789
- Conditions
- Infections, Ankle Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Apr 2024 (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.
The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).
Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.
Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin
| Arm | Type | Receives |
|---|---|---|
| Intravenous Vancomycin | Active comparator | Drug: Intravenous VancomycinPatients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS)) |
| Intraosseous Vancomycin | Experimental | Drug: Intraosseous Vancomycin InjectionIV antibiotics per physician's standard of care: Typically ancef or cefepime is started in pre-op within 1 hour of incision. IV Vancomycin will not be given preoperatively in this group. IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). IO Injection will take place into the medial malleolus. |
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 total ankle arthroplasty.
- Patient is able to give informed consent to participate in the study. LAR consents will not be utilized for this study
- Age Range >18
Key exclusion criteria (8 listed)
- Previous lower extremity surgery that in the opinion of the principal investigator or qualified research personnel precludes the participant from safely participating on the study.
- BMI > 40.
- Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).
- Inability to administer the IO infusion.
- Patient refusal to participate.
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 Vancomycin Injection* IO vancomycin is administered in the OR after sterile prep and draping has occurred (500mg in 100-150mL NS). * IO Injection will take place into the medial malleolus. | Drug | Intraosseous Vancomycin |
| Intravenous Vancomycin• Patients will receive the orthopedic surgeon's standard of care pre-operative antibiotic regimen for TAA 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 generally 1000-1750mg in 500mL normal saline (NS)) | Drug | Intravenous Vancomycin |
Primary outcome
Systemic Sample Vancomycin Tissue Concentration - Start of Case
Time frame: perioperatively
Systemic Sample Vancomycin Tissue Concentration - End of Case
Time frame: perioperatively
Capsule or Synovium Sample Vancomycin Tissue Concentration
Time frame: immediately after the procedure
Distal Tibia Sample Vancomycin Tissue Concentration
Time frame: immediately after the procedure
Talar Bone Sample Vancomycin Tissue Concentration
Time frame: immediately after the procedure
1 secondary outcome
90 day post-operative wound complication and infection rates
Time frame: 90 days after the procedure
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 24 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jason S Ahuero, MD principal investigator
The Methodist Hospital Research Institute
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 Vancomycin Injection and Intravenous Vancomycin in people with Infections and Ankle Arthritis, run by The Methodist Hospital Research Institute 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 8 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 24 Jan 2025. 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 Thomas C Sullivan, BS (346-238-1603, tsullivan@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Sample Vancomycin Tissue Concentration - Start of Case (time frame: perioperatively). The study lists 5 primary outcomes in all. 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 24 Jan 2025.