Results of Extended Versus Single Dose Antibiotic Prophylaxis In Orthopedic Revision Arthroplasty in Nijmegen.

NCT06402591 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: NL70114.091.19
• Study Type: interventional
• Target: 751
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized control trial is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin prophylaxis in revision arthroplasty of the hip and knee. The main question\[s\] it aims to answer are:

• Is an extended regimen compared to a single dose of cefazolin associated with an increased infection-free implant survival within one year after index revision arthroplasty of the hip or knee?
• What are the incidence, risk factors, treatment outcome and prognosis of surgical site infections and periprosthetic joint infection during follow-up?
• What is the safety and tolerance of the antimicrobial prophylaxis regimens used?
• What are the antimicrobial susceptibility patterns of micro-organisms causing PJI during follow-up?
• What is the patient' physical performance and satisfaction of subjects within 1 year after the index revision arthroplasty, using patient related outcome measurements (PROMS)? \[question 2\] Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].

Conditions

Infection Prosthesis Hip and Knee; Infection, Prosthesis Related; Joint Infection; Infection, Surgical Site; Surgical Site Infection; Infection Pro

Outcome Measures

Primary Outcomes (1)

• Success rate of revision arthroplasty

  1. Implant retention during follow-up, 2. No 'definite infection' score for PJI according to the Philadelphia consensus definition 2018 during follow-up 3. No PJI based on positive culture of a single synovial fluid or tissue sample yielding a high virulence micro-organism (S. aureus, Enterobacteriaceae, Pseudomonas spp, Acinetobacter spp, Candida spp) during follow-up. 4. No more than 4 consecutive weeks of systemic antimicrobial therapy for any reason during follow-up.

  1 year after revision arthroplasty

Secondary Outcomes (9)

• incidence surgical site infections

  1 year after revision arthroplasty

• incidence periprosthetic joint infection

  1 year after revision arthroplasty

• resistance rate of causative of SSI/PJI to cefazolin

  1 year after revision arthroplasty

• The number of repeated surgeries.

  1 year after revision arthroplasty

• Reason repeated surgery

  1 year after revision arthroplasty

Study Arms (2)

single dose cefazolin prophylaxis

NO INTERVENTION

prophylaxis according current guidelines single dose 2000mg cefazolin 15-30 minutes before incision

extended cefazolin prophylaxis

EXPERIMENTAL

5 days of cefazolin prophylaxis start dose 2000mg followed by 14 doses of 1000mg

Drug: Cefazolin

Interventions

Cefazolin DRUG

cefazolin extended prophylaxis 5 days (15 doses)

extended cefazolin prophylaxis

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older.
• Planned revision arthroplasty of the hip or knee prosthesis (index revision arthroplasty), with revision of one or more fixed components.

You may not qualify if:

• If the index revision arthroplasty has been cancelled.
• Revision of single mobile parts only.
• PJI on baseline, based on 'definite infection' score according to the Philadelphia consensus definition 2018
• PJI on baseline, based on a positive culture of a single synovial fluid or tissue sample yielding a high virulence micro-organism (S. aureus, Enterobacterales, Pseudomonas spp, Acinetobacter spp, Candida spp).
• Contraindication to cefazolin:
• a. Previous allergic reaction according to the criteria in Appendix A. b. Severe kidney disease defined as eGFR \<10 ml/min. f. Antimicrobial treatment within 3 days prior to index revision arthroplasty. g. Subjects who are currently enrolled in investigational immunosuppressive drug trials.
• h. Subjects who are unable to provide informed consent.

Sponsors & Collaborators

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

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, Netherlands

Location

MeSH Terms

Conditions

Prosthesis-Related Infections; Surgical Wound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wound Infection

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bart-Jan Kullberg, prof. Dr

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controled trial

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 7, 2024
• Study Start: January 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)