Intraarticular Antibiotic in TKA

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT04297631
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty and determine the serum concentrations of these antibiotics postoperatively.

Condition or Disease	Intervention/Treatment	Phase
Antibotics in Cementless Knees	Drug: Tobramycin Powder; Device: Vancomyscin	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 have tobramycin and vancomycin antibiotic powder placed into the knee during surgery. Postoperative drain fluid from the knee will be collected.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Study Investigating Antibiotic Elution From Free Intra-articular Vancomycin and Tobramycin After Cementless Total Knee Arthroplasty
• Actual Study Start Date: Feb 14, 2020
• Actual Primary Completion Date: Aug 1, 2020
• Actual Study Completion Date: Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vancomycin Powder All patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels.	Device: Vancomyscin; Everyone gets the vancomyscin powder.
Experimental: Tobramycin Powder All patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels.	Drug: Tobramycin Powder; Everyone gets tobramycin powder.

Outcome Measures

Primary Outcome Measures

1. Concentration of Antibiotics in Cementless Knees Post op [1 hour, 4 hours, and 24 hours]

   1. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty.

Secondary Outcome Measures

1. Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. [1 hour, 4 hours, and 24 hours]

   2. Determine the serum concentrations of these antibiotics postoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age over 18

2. Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

Exclusion Criteria:

1. Diminished mental capacity

2. Vancomycin allergy

3. Tobramycin allergy

4. Chronic kidney disease stage III and stage IV

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 10, 2020
• Informed Consent Form - Feb 13, 2020

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04297631
• Other Study ID Numbers: 201911147
• First Posted: Mar 5, 2020
• Last Update Posted: Oct 5, 2021
• Last Verified: Sep 1, 2021

• 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.: No
• Additional relevant MeSH terms: Tobramycin

Study Results

Participant Flow

Arm/Group Title	Vancomycin
Arm/Group Description	All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder.
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Vancomycin
Arm/Group Description	All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 35%
>=65 years	13 65%
Sex: Female, Male (Count of Participants)
Female	8 40%
Male	12 60%
Race and Ethnicity Not Collected (Count of Participants)
Vancomycin (Count of Participants)
Count of Participants [Participants]	20 100%

Outcome Measures

1. Primary Outcome

Title	Concentration of Antibiotics in Cementless Knees Post op
Description	1. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty.
Time Frame	1 hour, 4 hours, and 24 hours

Outcome Measure Data

Analysis Population Description

All primary cementless TKA two surgeons at a single institution over a 4-week period were assessed preoperatively for study inclusion.

Arm/Group Title	Intraarticular Concentrations of Tobramycin and Vancomycin
Arm/Group Description	All patients getting vancomycin and tobramycin to see serum concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder.
Measure Participants	20
1 hour Vancomycin Intraarticular concentration	1702.5
4 hour Vancomycin Intraarticular concentration	582.5
24 hour Vancomycin Intraarticular concentration	56.1
1 hour tobramycin Intraarticular concentration	1943
4 hour tobramycin Intraarticular concentration	345
24 hour tobramycin Intraarticular concentration	8.7

2. Secondary Outcome

Title	Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours.
Description	2. Determine the serum concentrations of these antibiotics postoperatively
Time Frame	1 hour, 4 hours, and 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vancomycin and Tobramycin Serum Concentration
Arm/Group Description	All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder.
Measure Participants	20
1 hour vancomycin serum concentration	2.3
4 hour vancomycin serum concentration	4.6
24 hour vancomycin serum concentration	3.1
1 hour tobramycin serum concentration	6.3
4 tobramycin	8
24 hour tobramycin	.8

Adverse Events

Time Frame	Adverse events were captured while patient was in hospital which was about 24 hours.
Adverse Event Reporting Description	study involved collecting fluid and blood from patients at post-op timepoints.
Arm/Group Title	Intraarticular Concentrations of Tobramycin and Vancomycin
Arm/Group Description	All patients getting vancomycin and tobramycin to see serum concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder.
All Cause Mortality
	Intraarticular Concentrations of Tobramycin and Vancomycin
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Intraarticular Concentrations of Tobramycin and Vancomycin
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Intraarticular Concentrations of Tobramycin and Vancomycin
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/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.