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.
Full Title of Study: “Drug Elution Profile and Minimum Inhibitory Concentration of Antibiotic-loaded Cement After Primary Total Knee Arthroplasty”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 20, 2022
- 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.
Arms, Groups and Cohorts
- Active Comparator: Group A (Control-negative group)
- include participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic
- Active Comparator: Group B (tobramycin group)
- includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.
- Active Comparator: Group C (gentamicin group)
- Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.
- Active Comparator: 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
Clinical Trial Outcome Measures
- 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
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Rothman Institute Orthopaedics
- Provider of Information About this Clinical Study
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