Can Intraosseous Antibiotics Improve the Results of Irrigation & Debridement and Prosthetic Retention for PJI?

PHASE4Enrolling by invitationINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 14, 2020

Primary Completion Date

January 1, 2026

Study Completion Date

June 1, 2026

Conditions
Joint Infection
Interventions
DRUG

Intraoperative Intraosseous Vancomycin

After debridement and irrigation the interventional group will receive intraosseous vancomycin 500mg in 150ml of normal saline. This solution will be prepared by the hospital pharmacy and administered via an EZ-IO intraosseous cannula. 75ccs of the vancomycin solution will be injected as a bolus. Subsequent to this the remaining 75ccs will be placed in the distal femur just proximal to the femoral component evenly split between the medial and lateral femoral condyles in knees.

Trial Locations (10)

10279

New York University - Langone, New York

28207

Atrium Mercy Hospital, Charlotte

OrthoCarolina Research Institute/OrthoCarolina, Charlotte

28209

Novant Health Charlotte Orthopedic Hospital, Charlotte

32607

University of Florida, Gainesville

33331

Cleveland Clinic Florida, Weston

60612

Rush University, Chicago

68105

University of Nebraska, Omaha

84112

University of Utah, Salt Lake City

94143

University of California, San Francisco, San Francisco

All Listed Sponsors
collaborator

American Association of Hip and Knee Surgeons

OTHER

lead

OrthoCarolina Research Institute, Inc.

OTHER