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

NCT05421312 | Unknown Phase 4 DMC

• 1 other identifier: 2022-13583
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (3)

• penetration cefazolin into synovial fluid

  The ratio (%) of the concentration of cefazolin in synovial fluid to serum.

  during surgical procedure prior to incision the synovial fluid sample will be taken

• penetration cefazolin into bone tissue

  The ratio (%) of the concentration of cefazolin in synovial fluid to serum.

  during surgical procedure prior to incision the synovial fluid sample will be taken

• penetration clindamycin into bone tissue

  The ratio (%) of the concentration of cefazolin in bone tissue to serum.

  during surgical procedure, directly after opening the joint and before reimplantation of the prosthesis the bone samples will be taken

Secondary Outcomes (4)

• AUC/MIC90 of cefazolin

  sampling during procedure

• AUC/MIC90 of clindamycin

  sampling during procedure

• factors associated with reduced cefazolin concentration

  sampling during procedure

• factors associated with reduced clindamycin concentration

  sampling during procedure

Study Arms (2)

cefazolin

OTHER

The cefazolin antimicrobial prophylaxis (2000mg single dose intravenously 15-60 minutes before incision) is part of standard of care.

Drug: sampling blood; Drug: Sampling synovial fluid; Drug: Sampling bone tissue

Clindamycin

OTHER

The clindamycin (600mg three times daily orally) PJI therapy is part of standard care.

Drug: sampling blood; Drug: Sampling synovial fluid; Drug: Sampling bone tissue

Interventions

sampling blood DRUG

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

Clindamycin; cefazolin

Sampling synovial fluid DRUG

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

Clindamycin; cefazolin

Sampling bone tissue DRUG

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

Clindamycin; cefazolin

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 16 years or older.
• Scheduled second stage revision arthroplasty (reimplantation) of the hip prosthesis during clindamycin 600mg three times a day orally for PJI, started at least 3 days before reimplantation (steady state).

You may not qualify if:

• Antibiotic prophylaxis other than cefazolin 2000mg i.v.
• Cefazolin use within 4 days previous to the reimplantation, other than the single dose administration of surgical prophylaxis just before incision.
• Clindamycin loaded bone cement in situ.
• BMI more than 35 kg/m2.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Sint Maartenskliniek: collaborator

MeSH Terms

Interventions

Cordocentesis

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Paracentesis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nynke Jager, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Jon Goosen, MD, PhD

  Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Veerman, MD

CONTACT

+31683845606; karin.veerman@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This explorative, low intervention study will be conducted in the Radboudumc Nijmegen and Sint Maartenskliniek (SMK) Nijmegen, The Netherlands. Subject will receive the cefazolin antibiotic prophylaxis and clindamycin antibiotic therapy as standard of care. The study interventions will include blood sampling on baseline and perioperative sampling of serum, synovial fluid and bone for the concentration measurements of the antibiotic agents. For every participating subject 3 serum samples, 1 synovial fluid sample and 2 bone samples will be taken for concentration measurement of cefazolin and clindamycin. Samples will be taken at different timepoints during the procedure.

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 16, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share