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Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA
Sponsor: Soren Overgaard
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 in patients with osteoarthritis undergoing primary THA. 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 20,000 primary THAs conducted at all public and private orthopedic departments in Denmark, this includes 36 sites corresponding to a total of 39 departments.
Official title: The Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With Osteoarthritis: A Cross-over, Cluster Randomized Controlled, Non-inferiority Trial Based on National Quality Databases. ProHipQ-OA
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20000
Start Date
2022-09-01
Completion Date
2025-03-01
Last Updated
2025-03-05
Healthy Volunteers
No
Interventions
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.
Locations (36)
Department of Orthopedic Surgery, Hospital of Southern Jutland, Aabenraa and Sønderborg
Aabenraa, Denmark
Capio Private Hospital, Aalborg
Aalborg, Denmark
Department of Orthopedic Surgery, Aalborg, Aalborg University Hospital
Aalborg, Denmark
Aleris Private Hospital, Aarhus
Aarhus, Denmark
Deaprtment of Orthopaedic Surgery, Aarhus University Hospital
Aarhus, Denmark
Capio Private Hospital, Aarhus
Aarhus C, Denmark
Capio Private Hospital, Gildhøj
Brøndby, Denmark
Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital - Bispebjerg and Frederiksberg
Copenhagen NV, Denmark
Adeas Private Hospital, Parken
Copenhagen Ø, Denmark
Department of Orthopedic Surgery, Esbjerg, Hospital of South West Jutland
Esbjerg, Denmark
Department of Orthopedic Surgery, Farsø, Aalborg University Hospital
Farsø, Denmark
CPH Private Hospital
Farum, Denmark
Department of Orthopedic Surgery, Frederikshavn, Aalborg University Hospital
Frederikshavn, Denmark
Department of Orthopedic Surgery, Grindsted, Hospital of South West Jutland
Grindsted, Denmark
Capio Private Hospital, Hellerup and Odense
Hellerup, Denmark
Department of Orthopaedic Surgery, Gentofte, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Denmark
Department of Orthopaedic Surgery, Herlev, Copenhagen University Hospital - Herlev and Gentofte
Herlev, Denmark
Department of Orthopedic Surgery, Gødstrup Regional Hospital
Herning, Denmark
Department of Orthopedic Surgery, Hillerød, Copenhagen University Hospital - North Zealand
Hillerød, Denmark
Department of Orthopedic Surgery, Copenhagen University Hospital - Holbæk
Holbæk, Denmark
Department of Orthopedic Surgery, Horsens Regional Hospital, Denmark
Horsens, Denmark
Department of Orthopedic Surgery, Hvidovre, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, Denmark
Acure Private Hospital
Kongens Lyngby, Denmark
Kollund Private Hospital, Kollund
Kruså, Denmark
Department of Orthopedic Surgery, Zealand University Hospital, Køge
Køge, Denmark
Department of Orthopedic Surgery, Copenahegn University Hospital - Nykøbing F
Nykøbing Falster, Denmark
Department for Planned Orthopaedic Surgery, Næstved, Copenhagen University Hospital - Næstved, Slagelse and Ringsted
Næstved, Denmark
Department of Orthopedic Surgery and Traumatology, Odense University Hospital and Svendborg Hospital
Odense, Denmark
Deparmtent of Orthopedic Surgery, Randers Regional Hospital
Randers, Denmark
Aleris Private Hospital, Ringsted
Ringsted, Denmark
Department of Surgery, Copenhagen University Hospital - Bornholm
Rønne, Denmark
Center for Planned Surgery, Silkeborg Regional Hospital
Silkeborg, Denmark
Aleris Private Hospital, Søborg
Søborg, Denmark
Department of Orthopedics, Lillebaelt Hospital, Vejle
Vejle, Denmark
Mølholm Private Hospital, Vejle
Vejle, Denmark
Deparmtent of Orthopedic Sugery, Viborg Regional Hospital
Viborg, Denmark