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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 19, 2018
Sponsor:
Collaborator:
American Association of Hip and Knee Surgeons
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

Brief Summary:

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.

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. 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two-arm, multi-center, randomized, superiority clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: How to Improve the Results of Irrigation and Debridement for PJI Through the Use of Intraosseous Antibiotics
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

I. Any patient with an acute perioperative periprosthetic infection or an acute hematogenous infection indicated for an irrigation debridement procedure of a hip or knee infection with a gram positive organism susceptible to vancomycin.

The patient must be deemed infected per MSIS criteria:

  1. A sinus communicating with the prosthesis OR
  2. Two positive cultures obtained from the prosthesis OR
  3. 3 of 5 criteria: (i) Elevated ESR (>30mm/hr) and CRP (>10mg/L) (ii) Elevated synovial leukocyte count (>3000 cells/μL) or change of ++ on leukocyte esterase strip (iii) Elevated synovial neutrophil percentage (>80%) (iv) One positive culture (v) Positive histological analysis of periprosthetic tissue (>5 neutrophils per high power field in 5 high power fields x400)

II. Acute perioperative periprosthetic infection in the first 90 days following primary surgery.

III. Acute hematogenous infection with symptoms less than four weeks.

Exclusion Criteria:

I. Any patient with a chronic infection or a surgical wound that cannot be closed.

II. Patients with PJI greater than 90 days following primary surgery. III. Acute hematogenous infection with symptoms greater than four weeks IV. Know hypersensitivity to Vancomycin V. Major Renal disease defined as creatinine > 1.5 (See previous comments, No Red Man syndrome in 2 subsequent studies on intraosseous vancomycin in revision TKA and High BMI patients respectively (10,11). Additional systematic levels were 8 times lower than IV Vancomycin.

VI. Unable to use a tourniquet due to vascular disease


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713528


Contacts
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Contact: Kelsey Edens 704-323-3845 kelsey.edens@orthocarolina.com
Contact: Susan Odum, PhD susan.odum@orthocarolina.com

Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
American Association of Hip and Knee Surgeons
Investigators
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Principal Investigator: Thomas Fehring, MD OrthoCarolina Research Institute, Inc.

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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03713528     History of Changes
Other Study ID Numbers: HK213
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Vancomycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents