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Antibiotic Loaded Cement After TKA

NCT05429671 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-20
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429671 on ClinicalTrials.gov