Antibiotic Loaded Cement After TKA

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Total Knee Arthoplasty
• Intervention / Treatment: Procedure: total knee arthroplasty; Drug: Tobramycin; Drug: Gentamicin; Device: Antibiotic cement spacer

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Control-negative group); include participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic	Procedure: total knee arthroplasty; Participants will have total knee arthroplasty
Active Comparator: Group B (tobramycin group); includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.	Procedure: total knee arthroplasty; Participants will have total knee arthroplasty; Drug: Tobramycin; Total knee arthroplasty using Stryker Surgical Simplex P with tobramycin
Active Comparator: Group C (gentamicin group); Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.	Procedure: total knee arthroplasty; Participants will have total knee arthroplasty; Drug: Gentamicin; Total knee arthroplasty using Huraeus Palacos R+G cement containing gentamicin
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	Procedure: total knee arthroplasty; Participants will have total knee arthroplasty; Device: Antibiotic cement spacer; participants getting an antibiotic-loaded cement spacer during surgery comprised of vancomycin and tobramycin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic concentration	To determine antibiotic levels, synovial fluid (joint fluid) would be taken after surgery to measure the concentration of antibiotic in the joint fluid	24 hours

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2022
• Primary Completion (Anticipated): June 20, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Bacterial Agents; Gentamicins; Tobramycin
• Other Study ID Numbers: MAUS21D.1213

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes