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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Antibiotic Elution in Total Knee Arthroplasty

Clinicaltrials.gov identifier NCT03928522

Recruitment Status Completed

First Posted April 26, 2019

Result First Posted November 2, 2020

Last update posted November 2, 2020

Study Description

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:Total Knee Replacement
  • Intervention/Treatment: Drug: hand mixed vancomycin
    Drug: hand mixed tobramycin
    Device: pre-mixed tobramycin
  • Phase: 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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • 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 2019
  • Actual Primary Completion Date: September 2019
  • Actual Study Completion Date: September 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: hand mixed vancomycin
patients will receive hand mixed vancomycin cement
Drug: hand mixed vancomycin
hand mixed vancomycin powder into cement
Experimental: hand-mixed vancomycin and tobramycin
patients will receive hand mixed vancomycin and tobramycin
Drug: hand mixed vancomycin
hand mixed vancomycin powder into cement

Drug: hand mixed tobramycin
hand mixed tobramycin into cement
Active Comparator: hand mixed tobramycin
patients will receive hand mixed tobramycin cement
Drug: hand mixed tobramycin
hand mixed tobramycin into cement
Active Comparator: Pre-mixed tobramycin
patients will receive pre-mixed tobramycin cement
Device: pre-mixed tobramycin
this cement is already pre-mixed with tobramycin
Outcome Measures
  • Primary Outcome Measures: 1. Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty [ Time Frame: 24 hours ]
    We wanted to measure the effect of elution level of vancomycin and tobramycin together
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

United States, Missouri
Washington University Orthopedics
Saint Louis

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Charles Lawrie, MD Washington University School of Medicine

More Information
  • 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: November 2, 2020
  • Last Verified: October 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Study Type: Interventional
  • Study Design: Allocation: Randomized;Intervention Model: Parallel Assignment;Masking: Single;Primary Purpose: Treatment
  • Condition: Total Knee Replacement
  • Interventions : Drug: hand mixed vancomycin
    Drug: hand mixed tobramycin
    Device: pre-mixed tobramycin
  • Enrollment: 60
Participant flow
Recruitment Details
Pre-assignment Details
Arm/Group title Intra-articular Vancomycin Hand-mixed Vancomycin and Tobramycin Hand Mixed Vancomycin Hand Mixed Tobramycin Pre-mixed Tobramycin
Arm/Group Description Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closure patients will receive hand mixed vancomycin and tobramycin hand mixed vancomycin: hand mixed vancomycin powder into cement hand mixed tobramycin: hand mixed tobramycin into cement patients will receive hand mixed vancomycin cement hand mixed vancomycin: hand mixed vancomycin powder into cement patients will receive hand mixed tobramycin cement hand mixed tobramycin: hand mixed tobramycin into cement patients will receive pre-mixed tobramycin cement pre-mixed tobramycin: this cement is already pre-mixed with tobramycin
Period Title: Overall Study
Started 12 12 12 12 12
Completed 12 12 12 12 12
Not Completed 0 0 0 0 0
Reason Not Completed
Baseline Characteristics
Arm/Group title TotalIntr-articular VancomycinHand-mixed Vancomycin and TobramycinHand Mixed VancomycinHand Mixed TobramycinPre-mixed Tobramycin
Arm/Group Description Total of all reporting groupsPatients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closurepatients will receive hand mixed vancomycin and tobramycin hand mixed vancomycin: hand mixed vancomycin powder into cement hand mixed tobramycin: hand mixed tobramycin into cementpatients will receive hand mixed vancomycin cement hand mixed vancomycin: hand mixed vancomycin powder into cementpatients will receive hand mixed tobramycin cement hand mixed tobramycin: hand mixed tobramycin into cementpatients will receive pre-mixed tobramycin cement pre-mixed tobramycin: this cement is already pre-mixed with tobramycin
Overall Number of Baseline Participants 601212121212
Baseline Analysis Population Description [Not Specified]
Region of Enrollment Measure Type: Number Unit of Measure: Participants Number Analyzed 60 Participants12 Participants12 Participants12 Participants12 Participants12 Participants
Outcome Measures
1. PrimaryOutcome
Title Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty
Description We wanted to measure the effect of elution level of vancomycin and tobramycin together
Time Frame 24 hours
Outcome Measure Data
Analysis Population Description
[Not Specified]
 
Arm/Group title Intr-articular VancomycinHand-mixed Vancomycin and TobramycinHand Mixed VancomycinHand Mixed TobramycinPre-mixed Tobramycin
Arm/Group Description Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closurepatients will receive hand mixed vancomycin and tobramycin hand mixed vancomycin: hand mixed vancomycin powder into cement hand mixed tobramycin: hand mixed tobramycin into cementpatients will receive hand mixed vancomycin cement hand mixed vancomycin: hand mixed vancomycin powder into cementpatients will receive hand mixed tobramycin cement hand mixed tobramycin: hand mixed tobramycin into cementpatients will receive pre-mixed tobramycin cement pre-mixed tobramycin: this cement is already pre-mixed with tobramycin
Overall Number of Participants Analyzed 1212121212
Measure Type: Median (Inter-Quartile Range)
Unit of Measure: mg/mL
1315
(429.0 to 2324.8)
16.2
(0.3 to 47.3)
12.6
(2.0 to 72.6)
30.6
(8.6 to 81.0)
23.9
(9.8 to 125.4)
Adverse Events
Time Frame Adverse event data was collected within 4-6 weeks after surgery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hand Mixed TobramycinPre-mixed TobramycinIntra-articular VancomycinHand-mixed Vancomycin and TobramycinHand Mixed Vancomycin
Arm/Group Description patients will receive hand mixed tobramycin cement hand mixed tobramycin: hand mixed tobramycin into cementpatients will receive pre-mixed tobramycin cement pre-mixed tobramycin: this cement is already pre-mixed with tobramycinpatients will receive powdered vancomycin into the wound before closurepatients will receive hand mixed vancomycin and tobramycin hand mixed vancomycin: hand mixed vancomycin powder into cement hand mixed tobramycin: hand mixed tobramycin into cementpatients will receive hand mixed vancomycin cement hand mixed vancomycin: hand mixed vancomycin powder into cement
All-Cause Mortality
  Pre-mixed Tobramycin Hand Mixed Tobramycin Hand Mixed Vancomycin Hand-mixed Vancomycin and Tobramycin Intra-articular Vancomycin
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 0/12 (0.00%) 0/12 (0.00%) 0/12 (0.00%) 0/12 (0.00%) 0/12 (0.00%)
Total
Total, all-cause mortality 0 /12 (0.00%) 0 /12 (0.00%) 0 /12 (0.00%) 0 /12 (0.00%) 0 /12 (0.00%)
Serious Adverse Events
  Pre-mixed Tobramycin Hand Mixed Tobramycin Hand Mixed Vancomycin Hand-mixed Vancomycin and Tobramycin Intra-articular Vancomycin
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 0/12 (0.00%) 0/12 (0.00%) 0/12 (0.00%) 0/12 (0.00%) 0/12 (0.00%)
Total
Total, serious adverse events 0 /12 (0.00%) 0 /12 (0.00%) 0 /12 (0.00%) 0 /12 (0.00%) 0 /12 (0.00%)
Show Other (Not Including Serious) Adverse Events
  Pre-mixed Tobramycin Hand Mixed Tobramycin Hand Mixed Vancomycin Hand-mixed Vancomycin and Tobramycin Intra-articular Vancomycin
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 0/12 (0.00%) 0/12 (0.00%) 0/12 (0.00%) 0/12 (0.00%) 0/12 (0.00%)
Total
Total, other adverse events 0 /12 (0.00%) 0 /12 (0.00%) 0 /12 (0.00%) 0 /12 (0.00%) 0 /12 (0.00%)
Limitations and Caveats

[Not Specified]

More Information
Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact
  • Name/Title:Venessa Riegler
  • Organization:Washington University
  • Phone:314-362-1721
  • EMail:rieglerv@wustl.edu
  • ClinicalTrials.gov Identifier: NCT03928522 History of Changes
  • Other Study ID Numbers: 201811101
  • First Submitted: January 29, 2019
  • First Posted: April 26, 2019
  • Results First Submitted: September 14, 2020
  • Results First Posted: November 2, 2020
  • Last Update Posted: November 2, 2020