Total Knee ReplacementPhase 4NCT03928522
Antibiotic Elution in Total Knee Arthroplasty
A Phase 4 study testing hand mixed vancomycin, hand mixed tobramycin and pre-mixed tobramycin in people with Total Knee Replacement, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- hand mixed vancomycin, hand mixed tobramycin and pre-mixed tobramycin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2019to 30 Sep 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.
- Primary diagnosis of knee osteoarthritis
Who cannot join
- Diminished mental capacity
- Vancomycin allergy
- Tobramycin allergy
- Patient history requiring IV administration of vancomycin or tobramycin perioperatively
- Chronic kidney disease stage III and stage IV
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Orthopedics
St Louis, Missouri, 63019
About this study
Official title: Prospective Randomized Study Investigating the Characterization of Antibiotics From Antibiotic Impregnated Cement After 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 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.
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 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.
- Conditions
- Total Knee Replacement
- Being tested
- hand mixed vancomycin, hand mixed tobramycin, pre-mixed tobramycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand mixed vancomycinDrug
Also called Vancomycin
hand mixed vancomycin powder into cement
hand mixed tobramycinDrug
Also called Tobramycin
hand mixed tobramycin into cement
pre-mixed tobramycinDevice
Also called Antibiotic PMMA bone cement
this cement is already pre-mixed with tobramycin
| Study group | Role | What they receive |
|---|---|---|
| Pre-mixed tobramycin | Active comparator | patients will receive pre-mixed tobramycin cement Receives: Device: pre-mixed tobramycin |
| hand mixed tobramycin | Active comparator | patients will receive hand mixed tobramycin cement Receives: Drug: hand mixed tobramycin |
| hand mixed vancomycin | Active comparator | patients will receive hand mixed vancomycin cement Receives: Drug: hand mixed vancomycin |
| hand-mixed vancomycin and tobramycin | Experimental | patients will receive hand mixed vancomycin and tobramycin Receives: Drug: hand mixed vancomycin; Drug: hand mixed tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty
We wanted to measure the effect of elution level of vancomycin and tobramycin together
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start28 Jan 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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 Total Knee ReplacementStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Lawrie, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928522
- Sponsor's protocol ID
- 201811101
- Status last verified
- Oct 2020
- First submitted
- 29 Jan 2019
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Investigating the Characterization of Antibiotics From Antibiotic Impregnated Cement After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03928522
- Acronym / sponsor ID
- 201811101
- Conditions
- Total Knee Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre-mixed tobramycin | Active comparator | Device: pre-mixed tobramycinpatients will receive pre-mixed tobramycin cement |
| hand mixed tobramycin | Active comparator | Drug: hand mixed tobramycinpatients will receive hand mixed tobramycin cement |
| hand mixed vancomycin | Active comparator | Drug: hand mixed vancomycinpatients will receive hand mixed vancomycin cement |
| hand-mixed vancomycin and tobramycin | Experimental | Drug: hand mixed vancomycin, Drug: hand mixed tobramycinpatients will receive hand mixed vancomycin and tobramycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18
- Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.
- Primary diagnosis of knee osteoarthritis
Key exclusion criteria (5 listed)
- Diminished mental capacity
- Vancomycin allergy
- Tobramycin allergy
- Patient history requiring IV administration of vancomycin or tobramycin perioperatively
- 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 |
|---|---|---|
| hand mixed vancomycinAlso: Vancomycinhand mixed vancomycin powder into cement | Drug | hand mixed vancomycin, hand-mixed vancomycin and tobramycin |
| hand mixed tobramycinAlso: Tobramycinhand mixed tobramycin into cement | Drug | hand mixed tobramycin, hand-mixed vancomycin and tobramycin |
| pre-mixed tobramycinAlso: Antibiotic PMMA bone cementthis cement is already pre-mixed with tobramycin | Device | Pre-mixed tobramycin |
Primary outcome
Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty
Time frame: 24 hours
We wanted to measure the effect of elution level of vancomycin and tobramycin together
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Total Knee Replacement
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REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
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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.
Charles Lawrie, MD principal investigator
Washington University School of Medicine
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 hand mixed vancomycin, hand mixed tobramycin and pre-mixed tobramycin in people with Total Knee Replacement, 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 3 inclusion and 5 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 2 Nov 2020. 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 2 Nov 2020). 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?
Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2020.