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

Elute, Inc. · NCT05361941

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
204
US sites recruiting
12
Study start
August 31, 2023
Record last updated
July 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: EP Granules with Tobramycin; empty voids

Conditions: Periprosthetic Joint Infections

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Southern California

    Los Angeles, CA 90033

    Site contact: Pui Yan · puiyan@med.usc.edu

  • Georgetown University Medical Center

    Washington D.C., DC 20007

    Site contact: Joshua Lawrence · 240-863-1681 · joshua.lawrence@medstar.net

  • Endeavor Health Skokie Hospital

    Skokie, IL 60076

    Site contact: John Carroll · 847-933-6328 · jcarroll@northshore.org

  • OrthoIndy

    Indianapolis, IN 46278

    Site contact: Melanie Glover · 317-802-2880 · mglover@orthoindy.com

  • Sinai Hospital

    Baltimore, MD 21215

    Site contact: Makayla Crosby · 410-601-2663 · mcrosby@lifebridgehealth.org

  • U Michigan Medical Center

    Ann Arbor, MI 48109

    Site contact: Justin Quimbo · 734-232-4145 · quimbo@med.umich.edu

  • Hospital for Special Surgery

    New York, NY 10021

    Site contact: Amar Ranawat, MD · 212-606-1000 · ranawatamar@hss.edu

  • OrthoCarolina

    Charlotte, NC 28204

    Site contact: Justin Norwood · 704-323-3845 · justin.norwood@orthocarolina.com

  • JIS Orthopedics

    Columbus, OH 43054

    Site contact: Michael Sneller · 614-964-0348 · snellerma@jisortho.com

  • Carrollton regional Medical Center

    Carrollton, TX 75010

    Site contact: Angela Mealing · 469-443-0924 · mealing@dallaslimbrestoration.com

  • UT Health San Antonio

    San Antonio, TX 78229

    Site contact: Jhemima Rizalde · 210-567-6176 · rizalde@uthscsa.edu

  • Jordan Valley Medical Center

    West Jordan, UT 84088

    Site contact: David Evans, MD · (801) 891-5056 · dcevans1@gmail.com

Study contacts (from the official record)

  • Ashok Khandkar, PhD · 801-410-4330 · ak@elutinc.com
  • Eva Serio, BS · 801-410-4330 · eva@elutinc.com
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