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Can Intraosseous Antibiotics Improve the Results of Irrigation & Debridement and Prosthetic Retention for PJI?
Sponsor: OrthoCarolina Research Institute, Inc.
Summary
Purpose of Study: In order to improve upon the variable results seen in irrigation and debridement for periprosthetic infection, we ask if the use of intraosseous regional administration of antibiotics at the time of irrigation and debridement will improve the modest success of standard irrigation and debridement. We will use the existing literature on standard irrigation and debridement procedures to compare with the results of the irrigation and debridement with the use of intraosseous antibiotics. Impact Question: How will this study benefit the patient? Currently when an I\&D fails, the patient needs to undergo two more major procedures: 1) implant removal and 2) reimplantation of the prosthesis. Any improvement in the results of a standard irrigation and debridement procedure may decrease the number of patients having to go through further extensive procedures to cure their infection.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2020-01-14
Completion Date
2027-06-01
Last Updated
2026-04-06
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (10)
University of California, San Francisco
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Rush University
Chicago, Illinois, United States
University of Nebraska
Omaha, Nebraska, United States
New York University - Langone
New York, New York, United States
Atrium Mercy Hospital
Charlotte, North Carolina, United States
OrthoCarolina Research Institute/OrthoCarolina
Charlotte, North Carolina, United States
Novant Health Charlotte Orthopedic Hospital
Charlotte, North Carolina, United States
University of Utah
Salt Lake City, Utah, United States