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

RecruitingNAAges 22 Years - anyAllElute, Inc.
NCT05361941 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study with two arms: a treatment arm (where subjects will be treated with the EP Granules + Tobramycin (EP G + T) investigational device, a combination device + antibiotic, in the 1st stage of a staged revision for periprosthetic joint infection (PJIs), and a control arm (where subjects are treated with the standard-of-care revision for infected PJIs).

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📋 Eligibility rules (as published)
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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What it tests

  • EP Granules with Tobramycin
  • empty voids
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Where

16 sites
University of Southern California
Los Angeles, United States
Georgetown University Medical Center
Washington D.C., United States
Endeavor Health Skokie Hospital
Skokie, United States
OrthoIndy
Indianapolis, United States
Sinai Hospital
Baltimore, United States
Massachusetts General Hospital
Boston, United States
Brigham & Womens Hospital
Boston, United States
U Michigan Medical Center
Ann Arbor, United States

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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