Antibiotic Elution in Total Knee Arthroplasty

Total Knee Replacement Clinical Trial

Official title:

Prospective Randomized Study Investigating the Characterization of Antibiotics From Antibiotic Impregnated Cement After Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928522
• Other study ID #: 201811101
• Status: Completed
• Phase: Phase 4
• Start date: January 28, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Drug:
• hand mixed vancomycin
hand mixed vancomycin powder into cement
• hand mixed tobramycin
hand mixed tobramycin into cement

Device:
• pre-mixed tobramycin
this cement is already pre-mixed with tobramycin

Locations

Country	Name	City	State
United States	Washington University Orthopedics	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty	We wanted to measure the effect of elution level of vancomycin and tobramycin together	24 hours