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NCT03928522 · ClinicalTrials.gov registry record · Phase 4
Antibiotic Elution in Total Knee Arthroplasty
A Phase 4 study of Total Knee Replacement, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03928522: Completed Phase 4 study of Total Knee Replacement, sponsored by Washington University School of Medicine.
NCT03928522 is a Phase 4 study of Total Knee Replacement that has completed, run by Washington University School of Medicine. The registered enrollment target is 60 participants, below the 209-participant average among 9 other Total Knee Replacement trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03928522, a Phase 4 study of Total Knee Replacement, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
We wanted to measure the effect of elution level of vancomycin and tobramycin together
Conditions Studied
Interventions
- DRUG hand mixed vancomycin
- DRUG hand mixed tobramycin
- DEVICE pre-mixed tobramycin
Study Locations (1)
Missouri
- Washington University Orthopedics - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-01-28 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 4 |
What the finished NCT03928522 record still lists
NCT03928522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 209-participant average among 9 other Total Knee Replacement trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Total Knee Replacement appearing as the primary indexed condition, and to 3 interventions - of which hand mixed vancomycin is the first listed.
NCT03928522 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03928522 about?
NCT03928522 is a clinical study titled "Antibiotic Elution in Total Knee Arthroplasty". 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 ...
What is the current status of trial NCT03928522?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2019-01-28. Estimated completion is 2019-09-30.
What conditions does trial NCT03928522 study?
This clinical trial studies the following conditions: Total Knee Replacement.
What interventions are being tested in trial NCT03928522?
The interventions under investigation include: hand mixed vancomycin (DRUG), hand mixed tobramycin (DRUG), pre-mixed tobramycin (DEVICE).
Who is sponsoring clinical trial NCT03928522?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03928522 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Total Knee Replacement
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Where NCT03928522's enrollment target sits among peer trials
60 7th of 9 higher than 2 of 9 other Total Knee Replacement trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Total Knee Replacement trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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