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NCT05429671
Antibiotic Loaded Cement After TKA
Phase 3 trial testing total knee arthroplasty in Total Knee Arthoplasty in 50 participants. Completed in 30 November 2023.
30 November 2023
Quick facts
| Lead sponsor | Rothman Institute Orthopaedics |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 20 June 2022 |
| Primary completion | 30 November 2023 |
| Estimated completion | 30 November 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- total knee arthroplasty — full drug profile →
- Tobramycin (tobramycin) — full drug profile →
- Gentamicin (GENTAMICIN) — full drug profile →
- Antibiotic cement spacer
Conditions studied
- Total Knee Arthoplasty — all drugs for Total Knee Arthoplasty →
Sponsor
Rothman Institute Orthopaedics
Who can join
18 and older, any sex, with Total Knee Arthoplasty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05429671
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of total knee arthroplasty
Trials testing the same drug.
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- NCT05833152 — Correlation Between Preoperative Knee Extension Lag and Functional Outcome After Total Knee Arthroplasty · completed
- NCT06122727 — Comparison of Custom and Standard Total Knee Replacements · NA · recruiting
- NCT05477745 — The Correlation Between Femoral Component Implanting Flexion Angle and Posterior Condyle Offset in Cruciate Retaining To · unknown
- NCT07515378 — Three Dimensional Gait Analysis After Total Knee Arthroplasty - Comparison of Objective and Patient-reported Outcomes Be · NA · completed
Other Rothman Institute Orthopaedics trials
Trials by the same sponsor.
- NCT06903767 — Automated V Manual Impactor Study · NA · enrolling by invitation
- NCT06601803 — Surgiphor Us in TSA · Phase 4 · enrolling by invitation
- NCT06575010 — Exparel v Dexamethasone in RCR · Phase 4 · enrolling by invitation
- NCT06536842 — Wound Drain After Lumbar Fusion Surgery · NA · enrolling by invitation
- NCT06484192 — Pain Control After Lumbar Spine Fusion · Phase 4 · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05429671 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rothman Institute Orthopaedics
- Last refreshed: 30 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05429671.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing