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Antibiotic-Releasing bone graft aims to fight infection and regrow bone in one step

NCT ID NCT05361941

Disease control Sponsor: Elute, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests a special bone graft that releases the antibiotic tobramycin to treat infected knee replacements. The graft is placed during the first stage of revision surgery, with the goal of clearing the infection and promoting new bone growth. About 200 adults with infected total knee replacements are randomly assigned to receive either the antibiotic-releasing graft or standard care. The study measures new bone formation at 12 months and infection control at 24 months, along with safety.

What this could mean

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

Active substance
a bone graft that releases the antibiotic tobramycin
What this could lead to
If it works, this could offer a better way to treat infected joint replacements, potentially reducing the need for multiple surgeries.
What could go wrong
This is a mid-stage trial, so the graft may not prove better than standard care. Risks include serious device-related side effects that could require another operation.

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 204 people

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

Started

Aug 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Ages and sexes eligible: at least 22 years, male and female * Candidates with known infected TKA * Life expectancy of at least 1 year * Patient is willing to provide informed consent, is geographically stable and able to comply with the required follow up visits, testing schedule and medication regimen * Adequate soft tissue coverage * Signed institutional review board approved informed consent Exclusion Criteria: * Severe renal impairment with eGFR \<50 ml/min/1.73 m2, or being treated with dialysis * Known hypersensitivity to aminoglycoside antibiotics, or calcium hydroxyapatite * Pre-existing calcium metabolism disorder * Uncontrolled diabetes mellitus (hemoglobin A1c levels \> 8) * A current endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, hyperthyroid parathyroid hormone disorder, Ehler- Danlos syndrome, osteogenesis imperfecta) * Neuromuscular disorders such as myasthenia gravis * Untreated malignant neoplasm(s), or currently undergoing radiation chemotherapy * Inadequate neurovascular status in the involved limb that may jeopardize healing * HIV * Pregnancy * Adult patients requiring a legal guardian to sign informed consent form

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Conditions

The condition(s) this trial relates to.

periprosthetic joint infection

As listed by the trial registrant

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

Periprosthetic joint infections

How to take part

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

  1. The places running it

    13 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

  • Brigham & Womens Hospital

    COMPLETED

    Boston, Massachusetts, 02115, United States

  • Carrollton regional Medical Center

    RECRUITING

    Carrollton, Texas, 75010, United States

  • Endeavor Health Skokie Hospital

    RECRUITING

    Skokie, Illinois, 60076, United States

  • Georgetown University Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Hospital for Special Surgery

    RECRUITING

    New York, New York, 10021, United States

  • JIS Orthopedics

    RECRUITING

    Columbus, Ohio, 43054, United States

  • Jordan Valley Medical Center

    RECRUITING

    West Jordan, Utah, 84088, United States

  • Massachusetts General Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • OrthoCarolina

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • OrthoIndy

    RECRUITING

    Indianapolis, Indiana, 46278, United States

  • Sanford South University Medical Center

    WITHDRAWN

    Fargo, North Dakota, 58103, United States

  • Sinai Hospital

    RECRUITING

    Baltimore, Maryland, 21215, United States

  • U Michigan Medical Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • UT Health San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • West Virginia University Medical Center

    WITHDRAWN

    Morgantown, West Virginia, 26506, United States

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