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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: Completed Phase 3 study, sponsored by Rothman Institute Orthopaedics.
NCT05429671 is a Phase 3 study that has completed, run by Rothman Institute Orthopaedics. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine antibiotic levels, synovial fluid (joint fluid) would be taken after surgery to measure the concentration of antibiotic in the joint fluid
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 |
What the finished NCT05429671 record still lists
NCT05429671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Gentamicin is the first listed.
NCT05429671 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05429671's enrollment target sits among peer trials
50 1844th of 2000 higher than 141 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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