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Antibiotic Elution in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03928522
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

The purpose of the study is to characterize and quantify the level of antibiotics eluted from antibiotic laden cement after primary cemented total knee arthroplasty.

Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria.

Patients that qualify and sign consent will be randomized to 1 of 4 antibiotic cement groups which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group. Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the knee postoperatively will be collected as well.


Condition or disease Intervention/treatment Phase
Total Knee Replacement Drug: hand mixed vancomycin Drug: hand mixed tobramycin Device: pre-mixed tobramycin Phase 4

Detailed Description:

Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria.

Patients that qualify and sign consent will be randomized to 1 of 4 antibiotic cement groups which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group. Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the knee postoperatively will be collected as well.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: patient will not know which antibiotic cement group they are in
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Investigating the Characterization of Antibiotics From Antibiotic Impregnated Cement After Total Knee Arthroplasty
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : January 28, 2020
Estimated Study Completion Date : June 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pre-mixed tobramycin
patients will receive pre-mixed tobramycin cement
Device: pre-mixed tobramycin
this cement is already pre-mixed with tobramycin
Other Name: Antibiotic PMMA bone cement

Active Comparator: hand mixed tobramycin
patients will receive hand mixed tobramycin cement
Drug: hand mixed tobramycin
hand mixed tobramycin into cement
Other Name: Tobramycin

Active Comparator: hand mixed vancomycin
patients will receive hand mixed vancomycin cement
Drug: hand mixed vancomycin
hand mixed vancomycin powder into cement
Other Name: Vancomycin

Experimental: hand-mixed vancomycin and tobramycin
patients will receive hand mixed vancomycin and tobramycin
Drug: hand mixed vancomycin
hand mixed vancomycin powder into cement
Other Name: Vancomycin

Drug: hand mixed tobramycin
hand mixed tobramycin into cement
Other Name: Tobramycin




Primary Outcome Measures :
  1. Amount of antibiotics eluted from pre-mixed cement versus hand-mixed cement with tobramycin after total knee arthroplasty [ Time Frame: 1 year ]
    difference in elution level from pre-mixed and hand mixed antibiotics


Secondary Outcome Measures :
  1. Determine the amount of vancomycin and tobramycin eluted from hand mixed cement with both antibiotics after total knee arthroplasty [ Time Frame: 1 year ]
    effect of elution level of vancomycin and tobramycin together



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18
  • Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.
  • Primary diagnosis of knee osteoarthritis

    • Exclusion Criteria:
  • Diminished mental capacity
  • Vancomycin allergy
  • Tobramycin allergy
  • Patient history requiring IV administration of vancomycin or tobramycin perioperatively
  • Chronic kidney disease stage III and stage IV

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): NCT03928522


Contacts
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Contact: Venessa Riegler, BS 314-362-1721 rieglerv@wustl.edu
Contact: Rondek Salih, MS 314-747-2495 salihrondek@wustl.edu

Locations
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United States, Missouri
Washington University Orthopedics Recruiting
Saint Louis, Missouri, United States, 63019
Contact: Venessa Riegler    314-362-1721 ext 3143621721    rieglerv@wustl.edu   
Contact: Venessa Riegler    3143621721 ext 3143621721    rieglerv@wustl.edu   
Principal Investigator: Charles Lawrie, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Charles Lawrie, MD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03928522     History of Changes
Other Study ID Numbers: 201811101
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a 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
Tobramycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents