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

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.

Conditions

• Fracture of Hip
• Total Hip Arthroplasty
• Prosthetic-joint Infection
• Fracture Acetabular

Interventions

OTHER

Antibiotic dosage practice

Patient inclusion starts day one, cross-over of departments from treatment A (single-dose) to B (multiple-dose) or vice versa after one year and end of inclusion happens after 2 years. All centers in Denmark use either Cloxacillin/Dicloxacillin, Cefuroxime or both drugs as standard prophylactic antibiotic practice for THA. In cases of cephalosporin allergy or general beta lactam allergy, the antibiotic clindamycin may be administered. In this trial, patients will be administered the standard prophylactic antibiotic practice of either single-dose (A) or multiple-doses (B) of antibiotics administered at each respective cluster that respective year. Both practices of dose administration for antibiotic prophylaxis (i.e. single- or multiple-dose) follow current standards of treatment and are based on present clinical practice guidelines.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• University Hospital Bispebjerg and Frederiksberg

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• University of Aarhus

  collaborator OTHER

• Sygehus Lillebaelt

  collaborator OTHER

• Soren Overgaard

  lead OTHER

Principal Investigators

• Armita A Abedi, MD · Copenhagen University Hospital, Bispebjerg Department of Orthopedic Surgery and Traumatology

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2025-04-01

Completion

2025-04-01

Countries

• Denmark

Study Locations