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Bone injection vs. IV: which antibiotic route wins for shoulder surgery?

NCT ID NCT05831774

Disease control Sponsor: The Methodist Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study tests whether injecting the antibiotic vancomycin directly into the shoulder bone works as well as giving it through a vein during shoulder replacement surgery. About 33 adults having shoulder replacement will be split into two groups to compare antibiotic levels in bone and tissue, and to check infection rates up to 90 days after surgery. The goal is to see if the bone injection is a safe and effective alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vancomycin
What this could lead to
If it works, this could show that giving antibiotics directly into the bone is just as good as through a vein, possibly reducing infections after shoulder replacement.
What could go wrong
This is a small, early-phase study with only 33 people, so results may not apply to everyone. There is also a risk of allergic reaction or side effects from the antibiotic.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

33 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Patient is undergoing anatomic or reverse shoulder arthroplasty * 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 shoulder surgery * BMI above 35 * 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 * Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo/radiation treatment in last 6 months, medications)

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Conditions

The condition(s) this trial relates to.

Shoulder Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Shoulder injuries

Contacts and locations

Locations

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.