Drug Elution Profile and Minimum Inhibitory Concentration of Antibiotic-loaded Cement After Primary Total Knee Arthroplasty
Overview
- Phase
- Phase 3
- Intervention
- total knee arthroplasty
- Conditions
- Total Knee Arthoplasty
- Sponsor
- Rothman Institute Orthopaedics
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Antibiotic concentration
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All participants undergoing cemented primary total knee arthroplasty (TKA) who are 18 years or older.
Exclusion Criteria
- •Withdrawal of informed consent,
- •allergy to any of the study medications or to bone cement,
- •use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis),
- •high risk of infection,
- •history of peri-articular injections for multimodal pain management.
Arms & Interventions
Group A (Control-negative group)
include participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic
Intervention: total knee arthroplasty
Group B (tobramycin group)
includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.
Intervention: total knee arthroplasty
Group B (tobramycin group)
includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.
Intervention: Tobramycin
Group C (gentamicin group)
Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.
Intervention: total knee arthroplasty
Group C (gentamicin group)
Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.
Intervention: Gentamicin
Group D (Control-positive group)
Include participants undergoing the first of a two-stage exchange arthroplasty for confirmed infection, using an antibiotic-loaded cement spacer. These patients will have a spacer implant made of vancomycin and tobramycin antibiotics using Huraeus Palacos non-antibiotic loaded cement
Intervention: total knee arthroplasty
Group D (Control-positive group)
Include participants undergoing the first of a two-stage exchange arthroplasty for confirmed infection, using an antibiotic-loaded cement spacer. These patients will have a spacer implant made of vancomycin and tobramycin antibiotics using Huraeus Palacos non-antibiotic loaded cement
Intervention: Antibiotic cement spacer
Outcomes
Primary Outcomes
Antibiotic concentration
Time Frame: 24 hours
To determine antibiotic levels, synovial fluid (joint fluid) would be taken after surgery to measure the concentration of antibiotic in the joint fluid