NCT05429671

Antibiotic Loaded Cement After TKA

Drug Elution Profile and Minimum Inhibitory Concentration of Antibiotic-loaded Cement After Primary Total Knee Arthroplasty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Total Knee Arthoplasty

Interventions

Type	Name	Description
PROCEDURE	total knee arthroplasty	Participants will have total knee arthroplasty
DRUG	Tobramycin	Total knee arthroplasty using Stryker Surgical Simplex P with tobramycin
DRUG	Gentamicin	Total knee arthroplasty using Huraeus Palacos R+G cement containing gentamicin
DEVICE	Antibiotic cement spacer	participants getting an antibiotic-loaded cement spacer during surgery comprised of vancomycin and tobramycin.

Timeline

• Start date: 2022-06-20
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2022-06-23
• Last updated: 2024-04-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study