NCT04297631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 5, 2021

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

March 3, 2020

Results QC Date

August 4, 2021

Last Update Submit

September 7, 2021

Conditions

Antibotics in Cementless Knees

Outcome Measures

Primary Outcomes (1)

  • Concentration of Antibiotics in Cementless Knees Post op

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

    1 hour, 4 hours, and 24 hours

Secondary Outcomes (1)

  • Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours.

    1 hour, 4 hours, and 24 hours

Study Arms (2)

Vancomycin Powder

EXPERIMENTAL

All patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels.

Device: Vancomyscin

Tobramycin Powder

EXPERIMENTAL

All patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels.

Drug: Tobramycin Powder

Interventions

Tobramycin PowderDRUG

Everyone gets tobramycin powder.

Tobramycin Powder
VancomyscinDEVICE

Everyone gets the vancomyscin powder.

Vancomycin Powder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18
  • Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

You may not qualify if:

  • Diminished mental capacity
  • Vancomycin allergy
  • Tobramycin allergy
  • Chronic kidney disease stage III and stage IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Results Point of Contact

Title
Venessa Riegler
Organization
Washington University
rieglerv@wustl.edu
3143621721

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

February 14, 2020

Primary Completion

August 1, 2020

Study Completion

November 1, 2020

Last Updated

October 5, 2021

Results First Posted

October 5, 2021

Record last verified: 2021-09

Locations

US(1)