Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture
NCT ID: NCT05530174
Last Updated: 2025-03-24
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
2000 participants
INTERVENTIONAL
2022-09-01
2025-04-01
Brief Summary
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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.
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Detailed Description
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Details regarding the Arms and Interventions:
The preoperative dose of antibiotic must be administered prior to surgical incision and in cases of delay with regards to planned surgical incision:
Dicloxacillin/Cloxacillin: If the preoperative antibiotic dose is administered \>60 minutes prior to surgical incision, the initial dose must be repeated.
Cefuroxime: If the preoperative antibiotic dose is administered \>90 minutes prior to surgical incision, the initial dose must be repeated.
Treatment A, Single-dose practice:
For patients ≥ 120 kg:
One preoperative single dose of either Dicloxacillin/Cloxacillin 3g OR Cefuroxime 3g administered intravenously prior to surgical incision.
In cases of cephalosporin allergy or general beta lactam allergy one preoperative single dose of Clindamycin 900mg administered intravenously, prior to surgical incision, regardless of weight.
Treatment B, Multiple-dose practice:
For patients ≥ 120 kg:
One preoperative single dose of either Dicloxacillin/Cloxacillin 3g OR Cefuroxime 3g administered intravenously prior to surgical incision, followed by 3 postoperative doses of Dicloxacillin/Cloxacillin 2g x 3 OR cefuroxime 1.5g x 3, administered within 24 hours after the preoperative dose, corresponding to 6, 12 and 18 hours postoperatively.
After the first postoperative dose, the remaining doses may be administered perorally for pragmatic reasons.
Dicloxacillin p.o. 1g, 12 and 18 hours postoperatively. OR Amoxicillin and clavulanic acid p.o. 875mg/125\*mg, 12 and 18 hours postoperatively.
\*If the center or region does not have access to amoxicillin and clavulanic acid 875/125mg a dose of 1g / 125mg (this means amoxicillin 500mg + amoxicillin and clavulanic acid 500mg/125 mg) may be administered.
In cases of cephalosporin allergy or general beta lactam allergy one preoperative single dose of Clindamycin 900mg administered intravenously, prior to surgical incision, regardless of weight, followed by 2 postoperative doses corresponding to:
For patients \<120kg: 300mg, 8 and 16 hours postoperatively. For patients ≥ 120kg: 600mg, 8 and 16 hours postoperatively. The same doses apply in cases of transmission to peroral antibiotics.
Implementation: The senior biostatistician is responsible for the randomization process of the centers. Each center will be allocated a code by the senior biostatistician responsible and reported to a central database. The randomization and allocation procedure will be known for the given year conditioning the given center.
Ethics and Dissemination: This trial has been approved by the Regional Ethical Committee (VEK) (21069108) and The Danish Medicines Agency (2021091723) without imposing an obligation to notify.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Treatment A, Single-dose practice
One preoperative single dose of either Dicloxacillin/Cloxacillin 2g OR Cefuroxime 1.5g administered intravenously prior to surgical incision.
As the study is a non-inferiority trial, we have chosen the Experimental design category.
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.
Treatment B, Multiple-dose practice
One preoperative dose of either Dicloxacillin/Cloxacillin 2g OR Cefuroxime 1.5g administered intravenously prior to surgical incision followed by 3 postoperative doses of Dicloxacillin/Cloxacillin 1g x 3 OR Cefuroxime 750mg x 3 within 24 hours after the preoperative dose.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER
Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Sygehus Lillebaelt
OTHER
Soren Overgaard
OTHER
Responsible Party
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Soren Overgaard
Clinical Professor, DMSc
Principal Investigators
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Armita A Abedi, MD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital, Bispebjerg Department of Orthopedic Surgery and Traumatology
Locations
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Department of Orthopedic Surgery, Aabenraa and Sønderborg, Hospital of Southern Jutland
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
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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ProHipQ Fracture
Identifier Type: -
Identifier Source: org_study_id
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