Skip to main content
OpenTrials
Completed

NCT Number: NCT05429671

Antibiotic Loaded Cement After TKA

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Knee Arthoplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total knee arthroplasty

Procedure

Participants will have total knee arthroplasty

Tobramycin

Drug

Total knee arthroplasty using Stryker Surgical Simplex P with tobramycin

Gentamicin

Drug

Total knee arthroplasty using Huraeus Palacos R+G cement containing gentamicin

Antibiotic cement spacer

Device

participants getting an antibiotic-loaded cement spacer during surgery comprised of vancomycin and tobramycin.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2022
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.