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NCT05429671 · ClinicalTrials.gov registry record · Phase 3
Antibiotic Loaded Cement After TKA
A Phase 3 study, sponsored by Rothman Institute Orthopaedics.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT05429671 is a Phase 3 study that has completed, run by Rothman Institute Orthopaedics. The registered enrollment target is 50 participants.
The verdict
NCT05429671, a Phase 3 study, has completed, sponsored by Rothman Institute Orthopaedics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
Study 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). 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.
Interventions
- DRUG Gentamicin
- DRUG Tobramycin
- PROCEDURE total knee arthroplasty
- DEVICE Antibiotic cement spacer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-06-20 |
| Est. Completion | 2023-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05429671
The ClinicalTrials.gov registry entry for NCT05429671 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rothman Institute Orthopaedics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Gentamicin is the first listed.
NCT05429671 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05429671 about?
NCT05429671 is a clinical study titled "Antibiotic Loaded Cement After TKA". 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). ...
What is the current status of trial NCT05429671?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2022-06-20. Estimated completion is 2023-11-30.
What interventions are being tested in trial NCT05429671?
The interventions under investigation include: Gentamicin (DRUG), Tobramycin (DRUG), total knee arthroplasty (PROCEDURE), Antibiotic cement spacer (DEVICE).
Who is sponsoring clinical trial NCT05429671?
This trial is sponsored by Rothman Institute Orthopaedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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