Antibotics in Cementless KneesPhase 4NCT04297631

Intraarticular Antibiotic in TKA

A Phase 4 study testing Tobramycin Powder and Vancomyscin in people with Antibotics in Cementless Knees, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Antibotics in Cementless Knees
What is being tested?: Tobramycin Powder and Vancomyscin
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2020to 1 Nov 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Prospective Study Investigating Antibiotic Elution From Free Intra-articular Vancomycin and Tobramycin After Cementless Total Knee Arthroplasty

Read the 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.

Conditions: Antibotics in Cementless Knees
Being tested: Tobramycin Powder, Vancomyscin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tobramycin PowderDrug
Everyone gets tobramycin powder.
VancomyscinDevice
Everyone gets the vancomyscin powder.

Study groups in NCT04297631
Study group	Role	What they receive
Vancomycin Powder	Experimental	All patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels. Receives: Device: Vancomyscin
Tobramycin Powder	Experimental	All patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels. Receives: Drug: Tobramycin Powder

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 hour, 4 hours, and 24 hours

Secondary outcomes (1)

Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours.
1. Determine the serum concentrations of these antibiotics postoperatively
Measured: 1 hour, 4 hours, and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20201 Nov 2020

First posted5 Mar 2020
Study start14 Feb 2020
Primary completion1 Aug 2020
Study completion1 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Antibotics in Cementless KneesStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04297631
Sponsor's protocol ID: 201911147
Status last verified: Sep 2021
First submitted: 3 Mar 2020
Last updated: 5 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Study Investigating Antibiotic Elution From Free Intra-articular Vancomycin and Tobramycin After Cementless Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT04297631
Acronym / sponsor ID: 201911147
Conditions: Antibotics in Cementless Knees
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 14 Feb 2020 (actual)
Primary completion: 1 Aug 2020 (actual)
Study completion: 1 Nov 2020 (actual)
First posted: 5 Mar 2020 (actual)
Results: Posted 5 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vancomycin Powder	Experimental	Device: VancomyscinAll patients getting vancomycin to see concentration after 24hrs in knee drain and serum levels.
Tobramycin Powder	Experimental	Drug: Tobramycin PowderAll patients getting Tobramycin to see conceration after 24hrs in knee drain and serum levels.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tobramycin PowderEveryone gets tobramycin powder.	Drug	Tobramycin Powder
VancomyscinEveryone gets the vancomyscin powder.	Device	Vancomycin Powder

Primary outcome

Concentration of Antibiotics in Cementless Knees Post op
Time frame: 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.

1 secondary outcome

Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours.
Time frame: 1 hour, 4 hours, and 24 hours

Results and safety

Results posted to the registry on 5 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vancomycin	20	20

Primary outcome: Concentration of Antibiotics in Cementless Knees Post op

Time frame: 1 hour, 4 hours, and 24 hours. Median (Full Range). Unit: micrograms per milliliter

Measure	Intraarticular Concentrations of Tobramycin and Vancomycin n = 20
1 hour Vancomycin Intraarticular concentration	1702.5 (440 to 4000)
4 hour Vancomycin Intraarticular concentration	582.5 (61 to 2400)
24 hour Vancomycin Intraarticular concentration	56.1 (12.4 to 290)
1 hour tobramycin Intraarticular concentration	1943 (345 to 7850)
4 hour tobramycin Intraarticular concentration	345 (31.8 to 1150)
24 hour tobramycin Intraarticular concentration	8.7 (1.5 to 358)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were captured while patient was in hospital which was about 24 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intraarticular Concentrations of Tobramycin and Vancomycin	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tobramycin Powder and Vancomyscin in people with Antibotics in Cementless Knees, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of Antibiotics in Cementless Knees Post op (time frame: 1 hour, 4 hours, and 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04297631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.