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Bone antibiotics: a new way to stop prosthetic infections?

NCT ID NCT07621094

Disease control Sponsor: Wake Forest University Health Sciences 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether giving antibiotics directly into the bone during surgery can prevent infections in people with osseointegration implants (a type of prosthetic that attaches directly to the bone). About 100 adults who already have or are getting these implants will receive vancomycin through a small tube in the bone during their operation. Researchers will track wound healing, infections, and any side effects for one year to see if this approach is safe and effective.

What this could mean

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

Active substance
vancomycin (antibiotic)
What this could lead to
If it works, this could offer a better way to prevent and treat infections in people with bone-anchored prosthetics, reducing the need for implant removal.
What could go wrong
This is an early-stage study with no comparison group, so it is unclear if the antibiotic delivery method is truly effective. There are also risks of antibiotic side effects like allergic reactions or kidney problems.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

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: * Treated with osseointegration for transfemoral, transhumeral, or transtibial amputation and presenting with concern for surgical site infection * \>18 years of age Exclusion Criteria: * Unable to follow up at site for 1 year * Patients that speak neither English nor Spanish * \<18 years of age

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Conditions

The condition(s) this trial relates to.

Infections prosthesis-related infectious disease

As listed by the trial registrant

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

Osseointegration infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104, United States