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

Part of paid clinical trials in San Francisco, California.

Sponsor
OrthoCarolina Research Institute, Inc.
Study ID
NCT03713528
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Joint Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Intraoperative Intraosseous Vancomycin — DRUG
    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.

Study Details

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 Dates

Start date
Jan 14, 2020
Status verified
Mar 2026
Primary completion
Jan 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Treatment Group
    The treatment group includes any patient with an acute perioperative periprosthetic infection, acute hematogenous infection, or unresectable infection with a gram positive organism sensitive to vancomycin and treated with intraoperative intraosseous vancomycin. Additionally, patients will be treated with at least 4 weeks of IV antibiotics under guidance of an infectious disease specialist, and indefinite antibiotic chronic suppression.

Primary Outcome Measure

Recurrence of Infection [ Time Frame: 1 year ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-
University of FloridaGainesvilleFlorida32607-
Cleveland Clinic FloridaWestonFlorida33331-
Rush UniversityChicagoIllinois60612-
University of NebraskaOmahaNebraska68105-
New York University - LangoneNew YorkNew York10279-
Atrium Mercy HospitalCharlotteNorth Carolina28207-
Novant Health Charlotte Orthopedic HospitalCharlotteNorth Carolina28209-
OrthoCarolina Research Institute/OrthoCarolinaCharlotteNorth Carolina28207-
University of UtahSalt Lake CityUtah84112-

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By research site
University of California, San Francisco· San Francisco, CAUniversity of Florida· Gainesville, FLCleveland Clinic Florida· Weston, FLRush University· Chicago, ILUniversity of Nebraska· Omaha, NENew York University - Langone· New York, NY

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