Not Yet RecruitingPhase 2/3

IO Vancomycin Spine

United States30 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Level of Systemic Vancomycin Concentration

Timeframe: Start of skin incision during surgery, Start of closure of skin incision during surgery

Level of Vancomycin Concentration in Bone

Timeframe: During surgery

Level of Vancomycin Concentration in Soft Tissue

Timeframe: During surgery

Trial details

NCT IDNCT06748144

SponsorThe Methodist Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Emily Vidal

346-238-4675 evidal@houstonmethodist.org

View on ClinicalTrials.gov More Lumbar Fusion Surgery trials