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

NARecruitingINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

August 31, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Periprosthetic Joint Infections
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

Trial Locations (12)

10021

RECRUITING

Hospital for Special Surgery, New York

26506

RECRUITING

West Virginia University Medical Center, Morgantown

43054

RECRUITING

JIS Orthopedics, Columbus

46278

RECRUITING

OrthoIndy, Indianapolis

48109

RECRUITING

U Michigan Medical Center, Ann Arbor

58103

RECRUITING

Sanford South University Medical Center, Fargo

60076

RECRUITING

Endeavor Health Skokie Hospital, Skokie

78229

RECRUITING

UT Health San Antonio, San Antonio

84088

RECRUITING

Jordan Valley Medical Center, West Jordan

90033

RECRUITING

University of Southern California, Los Angeles

02114

NOT_YET_RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Brigham & Womens Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Elute, Inc.

INDUSTRY