Trial Outcomes & Findings for Antibiotic Elution in Total Knee Arthroplasty (NCT NCT03928522)

NCT ID: NCT03928522

Last Updated: 2020-11-02

Results Overview

We wanted to measure the effect of elution level of vancomycin and tobramycin together

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

24 hours

Results posted on

2020-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Pre-mixed Tobramycin patients will receive pre-mixed tobramycin cement pre-mixed tobramycin: this cement is already pre-mixed with tobramycin	Hand Mixed Tobramycin patients will receive hand mixed tobramycin cement hand mixed tobramycin: hand mixed tobramycin into cement	Hand Mixed Vancomycin patients will receive hand mixed vancomycin cement hand mixed vancomycin: hand mixed vancomycin powder into cement	Hand-mixed Vancomycin and Tobramycin 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	Intra-articular Vancomycin Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closure
Overall Study STARTED	12	12	12	12	12
Overall Study COMPLETED	12	12	12	12	12
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-mixed Tobramycin n=12 Participants patients will receive pre-mixed tobramycin cement pre-mixed tobramycin: this cement is already pre-mixed with tobramycin	Hand Mixed Tobramycin n=12 Participants patients will receive hand mixed tobramycin cement hand mixed tobramycin: hand mixed tobramycin into cement	Hand Mixed Vancomycin n=12 Participants patients will receive hand mixed vancomycin cement hand mixed vancomycin: hand mixed vancomycin powder into cement	Hand-mixed Vancomycin and Tobramycin n=12 Participants 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	Intr-articular Vancomycin n=12 Participants Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closure	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=12 Participants	3 Participants n=12 Participants	6 Participants n=12 Participants	3 Participants n=12 Participants	7 Participants n=12 Participants	23 Participants n=60 Participants
Age, Categorical >=65 years	8 Participants n=12 Participants	9 Participants n=12 Participants	6 Participants n=12 Participants	9 Participants n=12 Participants	5 Participants n=12 Participants	37 Participants n=60 Participants
Sex: Female, Male Female	8 Participants n=12 Participants	4 Participants n=12 Participants	6 Participants n=12 Participants	6 Participants n=12 Participants	7 Participants n=12 Participants	31 Participants n=60 Participants
Sex: Female, Male Male	4 Participants n=12 Participants	8 Participants n=12 Participants	6 Participants n=12 Participants	6 Participants n=12 Participants	5 Participants n=12 Participants	29 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	12 participants n=12 Participants	12 participants n=12 Participants	12 participants n=12 Participants	12 participants n=12 Participants	60 participants n=60 Participants

PRIMARY outcome

Timeframe: 24 hours

We wanted to measure the effect of elution level of vancomycin and tobramycin together