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

RecruitingHealthy volunteers welcome

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

Sponsor: Elute, Inc. · Participants: 204 · Started: Aug 31, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05361941

Locations in the U.S.

CaliforniaUniversity of Southern California, Los Angeles
District of ColumbiaGeorgetown University Medical Center, Washington D.C.
IllinoisEndeavor Health Skokie Hospital, Skokie
IndianaOrthoIndy, Indianapolis
MarylandSinai Hospital, Baltimore
MassachusettsMassachusetts General Hospital, Boston (Not yet recruiting)
MichiganU Michigan Medical Center, Ann Arbor
New YorkHospital for Special Surgery, New York
North CarolinaOrthoCarolina, Charlotte
OhioJIS Orthopedics, Columbus
TexasCarrollton regional Medical Center, Carrollton
UT Health San Antonio, San Antonio
UtahJordan 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.