Total Knee ArthoplastyPhase 3NCT05429671
Antibiotic Loaded Cement After TKA
A Phase 3 study testing total knee arthroplasty, Tobramycin and Gentamicin in people with Total Knee Arthoplasty, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This study will provide us with clear information about the postoperative concentration of antibiotic reached in synovial fluid, thereby helping surgeons to determine if concentration could potentially prevent the growth and regrowth of common infecting microorganisms (based on their MIC and MBEC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthoplasty
- What is being tested?
- total knee arthroplasty, Tobramycin and Gentamicin
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2022to 30 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- All participants undergoing cemented primary total knee arthroplasty (TKA) who are 18 years or older.
Who cannot join
- Withdrawal of informed consent,
- allergy to any of the study medications or to bone cement,
- use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis),
- high risk of infection,
- history of peri-articular injections for multimodal pain management.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Drug Elution Profile and Minimum Inhibitory Concentration of Antibiotic-loaded Cement After Primary Total Knee Arthroplasty
This study will provide us with clear information about the postoperative concentration of antibiotic reached in synovial fluid, thereby helping surgeons to determine if concentration could potentially prevent the growth and regrowth of common infecting microorganisms (based on their MIC and MBEC). There is a need to define the actual benefit of antibiotic-loaded bone cement, because the addition of antibiotic can reduce its mechanical strength. Moreover, if sub-therapeutic antibiotic levels are achieved, this could facilitate the emergence of resistant bacterial strains. Amidst the transition towards value-based care, our research will enable surgeons to decide whether antibiotic-loaded cement is truly cost-effective in the prevention of PJI.
- Conditions
- Total Knee Arthoplasty
- Being tested
- total knee arthroplasty, Tobramycin, Gentamicin, Antibiotic cement spacer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyProcedure or surgery
Participants will have total knee arthroplasty
TobramycinDrug
Total knee arthroplasty using Stryker Surgical Simplex P with tobramycin
GentamicinDrug
Total knee arthroplasty using Huraeus Palacos R+G cement containing gentamicin
Antibiotic cement spacerDevice
participants getting an antibiotic-loaded cement spacer during surgery comprised of vancomycin and tobramycin.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control-negative group) | Active comparator | include participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic Receives: Procedure: total knee arthroplasty |
| Group B (tobramycin group) | Active comparator | includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic. Receives: Procedure: total knee arthroplasty; Drug: Tobramycin |
| Group C (gentamicin group) | Active comparator | Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic. Receives: Procedure: total knee arthroplasty; Drug: Gentamicin |
| Group D (Control-positive group) | Active comparator | Include participants undergoing the first of a two-stage exchange arthroplasty for confirmed infection, using an antibiotic-loaded cement spacer. These patients will have a spacer implant made of vancomycin and tobramycin antibiotics using Huraeus Palacos non-antibiotic loaded cement Receives: Procedure: total knee arthroplasty; Device: Antibiotic cement spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic concentration
To determine antibiotic levels, synovial fluid (joint fluid) would be taken after surgery to measure the concentration of antibiotic in the joint fluid
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 posted23 Jun 2022
- Study start20 Jun 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthoplastyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429671
- Sponsor's protocol ID
- MAUS21D.1213
- Status last verified
- Apr 2024
- First submitted
- 17 Jun 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Elution Profile and Minimum Inhibitory Concentration of Antibiotic-loaded Cement After Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05429671
- Acronym / sponsor ID
- MAUS21D.1213
- Conditions
- Total Knee Arthoplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide us with clear information about the postoperative concentration of antibiotic reached in synovial fluid, thereby helping surgeons to determine if concentration could potentially prevent the growth and regrowth of common infecting microorganisms (based on their MIC and MBEC). There is a need to define the actual benefit of antibiotic-loaded bone cement, because the addition of antibiotic can reduce its mechanical strength. Moreover, if sub-therapeutic antibiotic levels are achieved, this could facilitate the emergence of resistant bacterial strains. Amidst the transition towards value-based care, our research will enable surgeons to decide whether antibiotic-loaded cement is truly cost-effective in the prevention of PJI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (Control-negative group) | Active comparator | Procedure: total knee arthroplastyinclude participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic |
| Group B (tobramycin group) | Active comparator | Procedure: total knee arthroplasty, Drug: Tobramycinincludes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic. |
| Group C (gentamicin group) | Active comparator | Procedure: total knee arthroplasty, Drug: GentamicinInclude participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic. |
| Group D (Control-positive group) | Active comparator | Procedure: total knee arthroplasty, Device: Antibiotic cement spacerInclude participants undergoing the first of a two-stage exchange arthroplasty for confirmed infection, using an antibiotic-loaded cement spacer. These patients will have a spacer implant made of vancomycin and tobramycin antibiotics using Huraeus Palacos non-antibiotic loaded cement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All participants undergoing cemented primary total knee arthroplasty (TKA) who are 18 years or older.
Key exclusion criteria (5 listed)
- Withdrawal of informed consent,
- allergy to any of the study medications or to bone cement,
- use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis),
- high risk of infection,
- history of peri-articular injections for multimodal pain management.
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 |
|---|---|---|
| total knee arthroplastyParticipants will have total knee arthroplasty | Procedure or surgery | Group A (Control-negative group), Group B (tobramycin group), Group C (gentamicin group), Group D (Control-positive group) |
| TobramycinTotal knee arthroplasty using Stryker Surgical Simplex P with tobramycin | Drug | Group B (tobramycin group) |
| GentamicinTotal knee arthroplasty using Huraeus Palacos R+G cement containing gentamicin | Drug | Group C (gentamicin group) |
| Antibiotic cement spacerparticipants getting an antibiotic-loaded cement spacer during surgery comprised of vancomycin and tobramycin. | Device | Group D (Control-positive group) |
Primary outcome
Antibiotic concentration
Time frame: 24 hours
To determine antibiotic levels, synovial fluid (joint fluid) would be taken after surgery to measure the concentration of antibiotic in the joint fluid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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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.
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 3 study testing total knee arthroplasty, Tobramycin and Gentamicin in people with Total Knee Arthoplasty, run by Rothman Institute Orthopaedics 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 1 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 30 Apr 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Antibiotic concentration (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 30 Apr 2024; AzTrials last refreshed its copy on 27 Oct 2026.