Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT03713528
PHASE4

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

Sponsor: OrthoCarolina Research Institute, Inc.

View on ClinicalTrials.gov

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

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.

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