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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03713528
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : April 1, 2022
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 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.


Condition or disease Intervention/treatment Phase
Joint Infection Drug: Intraoperative Intraosseous Vancomycin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: multicenter, single arm, retrospective/prospective clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can Intraosseous Antibiotics Improve the Results of Irrigation & Debridement and Prosthetic Retention for PJI?
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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.
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.
Other Name: Vancomycin




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 (to be completed at time of consent) I. Acute perioperative periprosthetic infection in the first 90 days following primary surgery OR, II. Acute hematogenous infection with symptoms less than four weeks OR, III. Any patient with a chronic periprosthetic knee infection, or a prosthetic knee that is considered unresectable due to the presence of extremely difficult to extract implants such as cones/sleeves/or long cemented or cementless stems and indicated for an irrigation debridement procedure.

IV. Patients indicated for an irrigation debridement procedure of a knee periprosthetic knee joint infection as defined by the inclusion criteria noted above with a gram positive organism susceptible to vancomycin, defined as:

  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) We understand that on occasion, irrigation & debridement is performed emergently, therefore enrollment may continue without all laboratory/cultures completed. All inclusion criteria in this situation will be confirmed postoperatively.

V. Any patient >18 years old

Exclusion Criteria I. Surgical wound that cannot be closed. II. Patients with an acute PJI greater than 90 days following primary surgery (using standard implants).

III. Hematogenous infection with symptoms greater than four weeks IV. Know hypersensitivity to Vancomycin V. Major Renal disease defined as creatinine > 2.0 (See previous comments, No Red Man syndrome in 2 subsequent studies on intraosseous vancomycin in revision TKA and High BMI patients respectively (9). Additionally, systemic levels were 8 times lower with intraosseous antibiotics than IV Vancomycin.) VI. Unable to use a tourniquet due to vascular disease VII. Pregnant women VIII. Allergy to antibiotic

Screen Failure (following initial procedure):

IX. Culture negative infections whereby the infecting organism was not identified OR X. Vancomycin-resistant organisms


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


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Florida
Gainesville, Florida, United States, 32607
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68105
United States, New York
New York University - Langone
New York, New York, United States, 10279
United States, North Carolina
Atrium Mercy Hospital
Charlotte, North Carolina, United States, 28207
OrthoCarolina Research Institute/OrthoCarolina
Charlotte, North Carolina, United States, 28207
Novant Health Charlotte Orthopedic Hospital
Charlotte, North Carolina, United States, 28209
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
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.
Publications:

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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03713528    
Other Study ID Numbers: 9140
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022
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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Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents