Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities
Recruiting now · Not applicable
Conditions studied: Periprosthetic Joint Infections
In brief
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).
Key facts
- Study ID
- NCT05361941
- Run by
- Elute, Inc.
- People needed
- 204
- Starts
- 2023-08-31
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-07-14
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Southern California — Los Angeles, California, United States (enrolling)
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States (enrolling)
- Endeavor Health Skokie Hospital — Skokie, Illinois, United States (enrolling)
- OrthoIndy — Indianapolis, Indiana, United States (enrolling)
- Sinai Hospital — Baltimore, Maryland, United States (enrolling)
- JIS Orthopedics — Columbus, Ohio, United States (enrolling)
- Carrollton regional Medical Center — Carrollton, Texas, United States (enrolling)
- UT Health San Antonio — San Antonio, Texas, United States (enrolling)
- Jordan Valley Medical Center — West Jordan, Utah, United States (enrolling)
- U Michigan Medical Center — Ann Arbor, Michigan, United States (enrolling)
- Hospital for Special Surgery — New York, New York, United States (enrolling)
- OrthoCarolina — Charlotte, North Carolina, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham & Womens Hospital — Boston, Massachusetts, United States
- West Virginia University Medical Center — Morgantown, West Virginia, United States
- Sanford South University Medical Center — Fargo, North Dakota, United States
Full record on ClinicalTrials.gov
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