๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-13

Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities (NCT05361941)

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Elute, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: University of Southern California โ€” Los Angeles, California

Age range: 22 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (16 Sites)

  • University of Southern California โ€” Los Angeles, California
  • Georgetown University Medical Center โ€” Washington D.C., District of Columbia
  • Endeavor Health Skokie Hospital โ€” Skokie, Illinois
  • OrthoIndy โ€” Indianapolis, Indiana
  • Sinai Hospital โ€” Baltimore, Maryland
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Brigham & Womens Hospital โ€” Boston, Massachusetts
  • U Michigan Medical Center โ€” Ann Arbor, Michigan
  • Hospital for Special Surgery โ€” New York, New York
  • OrthoCarolina โ€” Charlotte, North Carolina
  • Sanford South University Medical Center โ€” Fargo, North Dakota
  • JIS Orthopedics โ€” Columbus, Ohio
  • Carrollton regional Medical Center โ€” Carrollton, Texas
  • UT Health San Antonio โ€” San Antonio, Texas
  • Jordan Valley Medical Center โ€” West Jordan, Utah
  • West Virginia University Medical Center โ€” Morgantown, West Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (801) 410-4330

Email: ak@elutinc.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—