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Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip

NCT05421312 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-06-16

No results posted yet for this study

Summary

To prevent periprosthetic joint infection (PJI), optimal penetration of antibiotics into the joint-space is needed. In revision arthroplasty, the incidence of PJI is increased compared to primary arthroplasty. In this study, the penetration of antibiotic agents into the synovial fluid and bone will be analyzed. The concentration of antibiotics will be related tot the to the susceptibility (minimal inhibitory concentration; MIC-90) of microorganisms that frequently cause PJI.

Conditions

  • PJI
  • Bone and Joint Infection
  • Pharmacokinetics

Interventions

DRUG

sampling blood

During the reimplantation, 3 serum samples will be taken at different timepoint during the procedure.

DRUG

Sampling synovial fluid

During the reimplantation 1 synovial fluid sample will be taken prior to incision.

DRUG

Sampling bone tissue

During the reimplantation 2 cortical bone samples will be taken at different timepoints during the procedure.

Sponsors & Collaborators

  • Sint Maartenskliniek

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Nynke Jager, PhD · Radboud University Medical Center

  • Jon Goosen, MD, PhD · Sint Maartenskliniek

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-09-30
Completion
2023-12-31

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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 NCT05421312 on ClinicalTrials.gov