Clinical Trial

Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture

Study acronym: ProHipQ-F
Active, Not Recruiting
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Record status
This record was last updated March 24, 2025 (before its estimated April 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
Aim: To compare the effect of one single dose versus multiple doses of prophylactic antibiotics administered within 24 hours, on the development of PJI after surgery in patients undergoing primary THA due to an acute fracture or sequelae of proximal femoral or acetabular fractures. The study is designed as a cross-over, cluster randomized, non-inferiority trial. All Danish orthopedic surgery departments performing primary THA with the majority being within inclusion criteria will be involved: Based on national quality databases, two-year cohorts of approximately 2,000 primary THAs due to a fracture or sequelae to a fracture, conducted at all public and private orthopedic departments in Denmark, this includes 36 sites corresponding to a total of 39 departments.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-09-02; most recent amendment 2025-03-19.
Status change: Completed → Active, Not Recruiting 2024-12-09
Status change: Recruiting → Completed 2024-12-01
Status change: Not Yet Recruiting → Recruiting 2022-09-07
Trial Details
NCT Number NCT05530174
Lead Sponsor Soren Overgaard
Collaborators: University of Copenhagen, University Hospital Bispebjerg and Frederiksberg, Odense University Hospital, Aarhus University Hospital, University of Aarhus, Sygehus Lillebaelt
Conditions Fracture of Hip, Total Hip Arthroplasty, Prosthetic-joint Infection, Fracture Acetabular
Enrollment 2,000 participants
Start Date 2022-09-01
Primary Completion 2025-04-01 (estimated)
Study Completion 2025-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-24