drugset / Trial / NCT05429671

Antibiotic Loaded Cement After TKA

NCT05429671

Phase 3 Completed 50 enrolled Rothman Institute Orthopaedics
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-06-20
Primary completion
2023-11-30
Completion
2023-11-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gentamicin Small molecule
Comparator Tobramycin Small molecule

Indications

No indication recorded.