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Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities
Who can join
Ages 22 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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).
What is being tested
- EP Granules with Tobramycin (device)
- empty voids (device)
Sponsor: Elute, Inc. · Participants: 204 · Started: Aug 31, 2023
Contact the study team
- Ashok Khandkar, PhD · Phone: 801-410-4330
- Eva Serio, BS · Phone: 801-410-4330
Official record on ClinicalTrials.gov — NCT05361941
Locations in the U.S.
| California | University of Southern California, Los Angeles |
| District of Columbia | Georgetown University Medical Center, Washington D.C. |
| Illinois | Endeavor Health Skokie Hospital, Skokie |
| Indiana | OrthoIndy, Indianapolis |
| Maryland | Sinai Hospital, Baltimore |
| Massachusetts | Massachusetts General Hospital, Boston (Not yet recruiting) |
| Michigan | U Michigan Medical Center, Ann Arbor |
| New York | Hospital for Special Surgery, New York |
| North Carolina | OrthoCarolina, Charlotte |
| Ohio | JIS Orthopedics, Columbus |
| Texas | Carrollton regional Medical Center, Carrollton UT Health San Antonio, San Antonio |
| Utah | Jordan Valley Medical Center, West Jordan |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.