Lumbar Fusion SurgeryPhase 2/3NCT06748144
IO Vancomycin Spine
A Phase 2/3 study testing Intraosseous Vancomycin and Intravenous Vancomycin in people with Lumbar Fusion Surgery, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The goal of this research is to learn if injecting the antibiotic vancomycin directly into the bone marrow (intraosseous) or IO) during a lumbar (spinal) fusion surgery, is as effective or better than the standard method of giving it vancomycin through a vein (intravenous) or IV) during lumbar fusion surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Fusion Surgery
- What is being tested?
- Intraosseous Vancomycin and Intravenous Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Apr 2030
- Phase
- Phase 2/3
- 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 open posterior instrumented spinal fusion (PSIF) or transforaminal lumbar interbody fusion (TLIF)
- Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study
- Age Range >18
Who cannot join
- Previous spine surgery if surgeon deems it will affect 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
- Refusal to participate
- Diabetes as defined as uncontrolled A1C > 7.5 and eGFR <59
- Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo/radiation treatment in last 6 months, medications)
- No 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
Houston Methodist Hospital
Houston, Texas, 77030
Emily Vidal, 346-238-4675, evidal@houstonmethodist.org
About this study
Official title: Intraosseous vs. Intravenous Vancomycin Administration in Spine Surgery
The goal of this research is to learn if injecting the antibiotic vancomycin directly into the bone marrow (intraosseous) or IO) during a lumbar (spinal) fusion surgery, is as effective or better than the standard method of giving it vancomycin through a vein (intravenous) or IV) during lumbar fusion surgery.
- Conditions
- Lumbar Fusion Surgery
- Being tested
- Intraosseous Vancomycin, Intravenous Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous VancomycinDrug
The intervention is specific to the method of administration that will be used when giving the dose of antibiotic vancomycin which is done to prevent infection following surgery.
Intravenous VancomycinDrug
This is the standard method of giving the antibiotic vancomycin to patients undergoing surgery across many specialties in order to prevent infection.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous Vancomycin | Experimental | Participants in this group will receive other antibiotics according to the Houston Methodist Hospital orthopedic surgeon's standard of care regimen, which typically involves ancef or cefepime being administered in pre-op within 1 hour of the incision. IO Vancomycin will be administered in the OR after incision (500mg in 100-150mL normal saline (NS)), and the injection will be placed into the posterior ilium. Receives: Drug: Intraosseous Vancomycin |
| Intravenous Vancomycin | Active comparator | Patients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for lumbar fusion patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin), which 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 NS). Receives: Drug: Intravenous Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Level of Systemic Vancomycin Concentration
The level of vancomycin concentration will be assessed via a blood draw by the anesthesiologist staff.
Measured: Start of skin incision during surgery, Start of closure of skin incision during surgery
Level of Vancomycin Concentration in Bone
Bony tissue samples (Superior Articular Process, Inferior Articular Process, and Lamina) will be taken during surgery to assess levels of vancomycin concentration in the bone.
Measured: During surgery
Level of Vancomycin Concentration in Soft Tissue
Soft tissue samples (Multifidus muscle, Fat) will be taken during surgery to assess levels of vancomycin concentration in the tissue.
Measured: During surgery
Secondary outcomes (1)
Post-Operative Complication Rates
Participant's charts will be reviewed postoperatively to determine if there were any adverse local/systemic reactions and/or complications following the surgery.
Measured: 30 Days Post Surgery, 90 Days Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study startMay 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Fusion SurgeryStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Prasarn, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748144
- Sponsor's protocol ID
- PRO00038766
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraosseous vs. Intravenous Vancomycin Administration in Spine Surgery
- ClinicalTrials.gov ID
- NCT06748144
- Acronym / sponsor ID
- PRO00038766
- Conditions
- Lumbar Fusion Surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 27 Dec 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 goal of this research is to learn if injecting the antibiotic vancomycin directly into the bone marrow (intraosseous) or IO) during a lumbar (spinal) fusion surgery, is as effective or better than the standard method of giving it vancomycin through a vein (intravenous) or IV) during lumbar fusion surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraosseous Vancomycin | Experimental | Drug: Intraosseous VancomycinParticipants in this group will receive other antibiotics according to the Houston Methodist Hospital orthopedic surgeon's standard of care regimen, which typically involves ancef or cefepime being administered in pre-op within 1 hour of the incision. IO Vancomycin will be administered in the OR after incision (500mg in 100-150mL normal saline (NS)), and the injection will be placed into the posterior ilium. |
| Intravenous Vancomycin | Active comparator | Drug: Intravenous VancomycinPatients will receive the Houston Methodist Hospital orthopedic surgeon's standard of care pre-operative antibiotic regimen for lumbar fusion patients. This includes IV antibiotics (typically ancef or cefepime and vancomycin), which 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 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 open posterior instrumented spinal fusion (PSIF) or transforaminal lumbar interbody fusion (TLIF)
- Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study
- Age Range >18
Key exclusion criteria (8 listed)
- Previous spine surgery if surgeon deems it will affect 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
- 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 VancomycinThe intervention is specific to the method of administration that will be used when giving the dose of antibiotic vancomycin which is done to prevent infection following surgery. | Drug | Intraosseous Vancomycin |
| Intravenous VancomycinThis is the standard method of giving the antibiotic vancomycin to patients undergoing surgery across many specialties in order to prevent infection. | Drug | Intravenous Vancomycin |
Primary outcome
Change in Level of Systemic Vancomycin Concentration
Time frame: Start of skin incision during surgery, Start of closure of skin incision during surgery
The level of vancomycin concentration will be assessed via a blood draw by the anesthesiologist staff.
Level of Vancomycin Concentration in Bone
Time frame: During surgery
Bony tissue samples (Superior Articular Process, Inferior Articular Process, and Lamina) will be taken during surgery to assess levels of vancomycin concentration in the bone.
Level of Vancomycin Concentration in Soft Tissue
Time frame: During surgery
Soft tissue samples (Multifidus muscle, Fat) will be taken during surgery to assess levels of vancomycin concentration in the tissue.
1 secondary outcome
Post-Operative Complication Rates
Time frame: 30 Days Post Surgery, 90 Days Post Surgery
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 25 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intraosseous Vancomycin and Intravenous Vancomycin in people with Lumbar Fusion Surgery, 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: opening soon, as of the sponsor's last update on 25 Mar 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Emily Vidal (346-238-4675, evidal@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Level of Systemic Vancomycin Concentration (time frame: Start of skin incision during surgery, Start of closure of skin incision during surgery). The study lists 3 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 25 Mar 2026.