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Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
Sponsor: Elute, Inc.
Summary
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 with Tobramycin investigational device 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 Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2023-08-31
Completion Date
2025-12-31
Last Updated
2025-01-08
Healthy Volunteers
Yes
Conditions
Interventions
EP Granules with Tobramycin
EP Granules with Tobramycin is a Ca-salt resorbable intended for orthopedic applications as a bone void filler for bone gaps or voids and in cases where risk of post-operative infection is high, such as the first stage of a 2-stage or 1.5 stage revision of an infected total joint.
empty voids
Voids are left empty
Locations (12)
University of Southern California
Los Angeles, California, United States
Endeavor Health Skokie Hospital
Skokie, Illinois, United States
OrthoIndy
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Womens Hospital
Boston, Massachusetts, United States
U Michigan Medical Center
Ann Arbor, Michigan, United States
Hospital for Special Surgery
New York, New York, United States
Sanford South University Medical Center
Fargo, North Dakota, United States
JIS Orthopedics
Columbus, Ohio, United States
UT Health San Antonio
San Antonio, Texas, United States
Jordan Valley Medical Center
West Jordan, Utah, United States
West Virginia University Medical Center
Morgantown, West Virginia, United States