How to Improve the Results of Irrigation and Debridement for PJI Through the Use of Intraosseous Antibiotics
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|ClinicalTrials.gov Identifier: NCT03713528|
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 2, 2019
Purpose of Study: In order to improve upon the modest results seen in irrigation and debridement for periprosthetic infection and limit the number of surgical procedures performed we ask if the use of intraosseous regional administration of antibiotics at the time of irrigation and debridement would further improve the results of irrigation debridement for prosthetic joint infection.
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. Since I&D currently fails up to 2/3 of the time, any improvement will decrease the number of patients having to go through two procedures to cure their infection.
|Condition or disease||Intervention/treatment||Phase|
|Joint Infection||Drug: Intraoperative Intraosseous Vancomycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||two-arm, multi-center, randomized, superiority clinical trial|
|Masking:||None (Open Label)|
|Official Title:||How to Improve the Results of Irrigation and Debridement for PJI Through the Use of Intraosseous Antibiotics|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
Active Comparator: Treatment Group
The treatment group includes any patient with an acute perioperative periprosthetic infection, or acute hematogenous 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.
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. In hips, the remaining 75ccs is placed into the supra acetabular region through the cannula.
Other Name: Vancomycin
No Intervention: Comparison Group
The control group includes any patient with an acute perioperative periprosthetic, or acute hematogenous infection with a vancomycin sensitive gram positive organism treated with intravenous vancomycin. Additionally, patients will be treated with at least 4 weeks of IV antibiotics, and indefinite antibiotic chronic suppression under guidance of an infectious disease specialist.
- Recurrence of Infection [ Time Frame: 1 year ]The primary outcome measured will be the recurrence of infection by the same organism or reinfection with a new organism as determined by the criteria using the International Consensus Meeting on PJI (1 year follow-up).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713528
|Contact: Kelsey Edensfirstname.lastname@example.org|
|Contact: Susan Odum, PhDemail@example.com|
|Principal Investigator:||Thomas Fehring, MD||OrthoCarolina Research Institute, Inc.|