Clinical Trial

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

Enrolling by Invitation Phase 4
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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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2018-10-18; most recent amendment 2026-03-31.
Status change: Not Yet Recruiting → Enrolling by Invitation 2020-09-14
Trial Details
NCT Number NCT03713528
Lead Sponsor OrthoCarolina Research Institute, Inc.
Collaborators: American Association of Hip and Knee Surgeons
Conditions Joint Infection
Enrollment 100 participants
Start Date 2020-01-14
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-06