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Study of EP Granules with Tobramycin for Infected Joint Replacements

This study is testing a new approach for people with periprosthetic joint infections (PJIs), which are infections around joint replacements. It compares a device called EP Granules with Tobramycin to the standard treatment. EP Granules with Tobramycin is a special material designed to fill bone gaps and help prevent infection during the first surgery of a two-stage joint revision. The goal is to see if this device can help new bone grow better and reduce the chance of the infection coming back, while also being safe. You might be eligible if you are at least 22 years old, have an infected knee replacement, and can commit to follow-up visits. The study aims to enroll 204 participants, but its current status is unclear.

Study design
This is a multi-center, randomized study with two groups: one receiving EP Granules with Tobramycin and one receiving standard care. Neither you nor your doctors will know which treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be monitored for 24 months after your first surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05361941

Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities

Recruiting
NAAges 22+InterventionalTreatment
Elute, Inc.
~204 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:EP Granules with Tobramycinempty voids

At a glance

Recruiting sites
12 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events.
Measured over 24 months after stage 1 surgery
+1 more outcome measured

Conditions

Periprosthetic Joint Infections

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Peri-prosthetic Joint Infection

NCT05361941

Where you'd take part

This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Carrollton regional Medical Center

    Carrollton, Texasstudy coordinator listed

    Recruiting

  • Endeavor Health Skokie Hospital

    Skokie, Illinoisstudy coordinator listed

    Recruiting

  • Georgetown University Medical Center

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

  • Hospital for Special Surgery

    New York, New Yorkstudy coordinator listed

    Recruiting

  • JIS Orthopedics

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • Jordan Valley Medical Center

    West Jordan, Utahstudy coordinator listed

    Recruiting

  • OrthoCarolina

    Charlotte, North Carolinastudy coordinator listed

    Recruiting

  • OrthoIndy

    Indianapolis, Indianastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bruce Evans, MD · STUDY_CHAIR · Holy Cross Jordan Valley Hospital

Who to contact

Ashok Khandkar, PhD
[email protected]
801-410-4330
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events.24 months after stage 1 surgery

    A\] New bone growth observed in voids at 12 months versus pre-op stage 1 and B\] Absence of infection at 24 months versus pre-op stage 1 surgery.

  • Absence of serious device related adverse events requiring re- operation24 months after stage 1 surgery

    A serious device related adverse event requiring re-operation * Success = no adverse event occurs * Failure = adverse event occurs