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RECRUITING
NCT05361941
NA

Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities

Sponsor: Elute, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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