- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05530174
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture (ProHipQ-F)
The Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture: A Cross-over, Cluster Randomized Controlled, Non-inferiority Trial Based on National Quality Databases: ProHipQ-F
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
The outcome measures will be extracted from the following national databases: The Civil Registration System (CRS), The Danish Hip Arthroplasty Register (DHR), The Danish National Patient Registry (DNRP), The Hospital Acquired Infections Database (HAIBA), The Danish National Prescription Database (NPR), Statistics Denmark and Danish Agency for Labour Market and Recruitment registry (STAR).
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
Study Contact Backup
- Name: Søren Overgaard, DMsc
- Phone Number: +4520634079
- Email: soeren.overgaard@regionh.dk
Study Locations
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Aabenraa, Denmark, 6200/6400
- Recruiting
- Department of Orthopedic Surgery, Aabenraa and Sønderborg, Hospital of Southern Jutland
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Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
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Contact:
- Jens Knoke, MD
- Phone Number: +4579977195
- Email: jens.knoke@rsyd.dk
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Aalborg, Denmark, 9000
- Recruiting
- Capio Private Hospital, Aalborg
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Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
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Contact:
- Poul T Nielsen, MD
- Phone Number: +4598392244
- Email: ptn@capio.dk
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Aalborg, Denmark, 9000
- Recruiting
- Department of Orthopedic Surgery, Aalborg, Aalborg University Hospital
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Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Thomas Jakobsen, MD PhD DMSc
- Phone Number: 20653064
- Email: thomas.jakobsen@rn.dk
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Aarhus, Denmark, 8200
- Recruiting
- Aleris Private Hospital, Aarhus
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Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
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Contact:
- Thomas Prynø, MD
- Phone Number: +4530620352
- Email: Thomas.Pryno@aleris.dk
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Aarhus, Denmark, 8200
- Recruiting
- Deaprtment of Orthopaedic Surgery, Aarhus University Hospital
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Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
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Contact:
- Stig S Jakobsen, MD, PhD
- Phone Number: +4540976165
- Email: stigjako@rm.dk
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Aarhus C, Denmark, 8000
- Recruiting
- Capio Private Hospital, Aarhus
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Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
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Contact:
- Niels K Jensen, MD
- Phone Number: +4586121200
- Email: nkr@capio.dk
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Brøndby, Denmark, 2605
- Recruiting
- Capio Private Hospital, Gildhøj
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Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
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Contact:
- Micael Haugegaard, MD
- Phone Number: +4570878328
- Email: mh@gildhoj.dk
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Copenhagen NV, Denmark, 2400
- Recruiting
- Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital - Bispebjerg and Frederiksberg
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Contact:
- Søren Overgaard, MD, DMSc
- Phone Number: +4520634079
- Email: soeren.overgaard@regionh.dk
-
Contact:
- Armita A Abedi, MD
- Phone Number: +51358644
- Email: armita.armina.abedi@regionh.dk
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Copenhagen Ø, Denmark, 2100
- Recruiting
- Adeas Private Hospital, Parken
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Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Anne Marie Sørensen, MD, PhD
- Phone Number: +4588774000
- Email: ams@adeas.dk
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Esbjerg, Denmark, 6700
- Recruiting
- Department of Orthopedic Surgery, Esbjerg, Hospital of South West Jutland
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Lars L Hermansen, MD, PhD
- Phone Number: +4528120908
- Email: Lars.Lykke.Hermansen@rsyd.dk
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Farsø, Denmark, 9640
- Recruiting
- Department of Orthopedic Surgery, Farsø, Aalborg University Hospital
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Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
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Contact:
- Mathias B Rasmussen, MD
- Phone Number: +4597662548/+455126 9790
- Email: mathias.rasmussen@rn.dk
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Farum, Denmark, 3520
- Recruiting
- CPH Private Hospital
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Jens Nørgaard, MD
- Email: jen@cph-privathospital.dk
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Frederikshavn, Denmark, 9900
- Recruiting
- Department of Orthopedic Surgery, Frederikshavn, Aalborg University Hospital
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Anders M Diernæs, MD
- Phone Number: +4530338683
- Email: anders.diernaes@rn.dk
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Grindsted, Denmark, 7200
- Recruiting
- Department of Orthopedic Surgery, Grindsted, Hospital of South West Jutland
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Lars L Hermansen, MD, PhD
- Phone Number: +4528120908
- Email: Lars.Lykke.Hermansen@rsyd.dk
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Hellerup, Denmark, 2900/5000
- Recruiting
- Capio Private Hospital, Hellerup and Odense
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Christian Hofbauer, MD
- Phone Number: +4539777070
- Email: cho@capio.dk
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Hellerup, Denmark, 2900
- Recruiting
- Department of Orthopaedic Surgery, Gentofte, Copenhagen University Hospital - Herlev and Gentofte
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Søren Solgaard, MD, DMSc
- Email: soeren.solgaard@regionh.dk
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Herlev, Denmark, 2730
- Recruiting
- Department of Orthopaedic Surgery, Herlev, Copenhagen University Hospital - Herlev and Gentofte
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Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Jens Peter Alva-Jørgensen, MD
- Phone Number: +4538689565
- Email: Jens.Peter.Alva-Joergensen@regionh.dk
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Herning, Denmark, 7400
- Recruiting
- Department of Orthopedic Surgery, Gødstrup Regional Hospital
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Dovydas Vainorius, MD
- Email: dovyvain@rm.dk
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Hillerød, Denmark, 3400
- Recruiting
- Department of Orthopedic Surgery, Hillerød, Copenhagen University Hospital - North Zealand
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Simon Serbian, MD
- Email: simon.serbian@regionh.dk
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Holbæk, Denmark, 4300
- Recruiting
- Department of Orthopedic Surgery, Copenhagen University Hospital - Holbæk
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Steffen H Bruun, MD
- Phone Number: +4523462462
- Email: sthl@regionsjaelland.dk
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Horsens, Denmark, 8700
- Recruiting
- Department of Orthopedic Surgery, Horsens Regional Hospital, Denmark
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Jeppe Lange, MD, PhD
- Phone Number: +4526853290
- Email: jepplang@rm.dk
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Hvidovre, Denmark, 2650
- Recruiting
- Department of Orthopedic Surgery, Hvidovre, Copenhagen University Hospital - Amager and Hvidovre
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Christian S Nielsen, MD, PhD
- Email: Christian.Skovgaard.Nielsen@regionh.dk
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Kongens Lyngby, Denmark, 2800
- Recruiting
- Acure Private Hospital
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Thomas Kjær, MD
- Email: TKI@acureph.dk
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Kruså, Denmark, 6340
- Recruiting
- Kollund Private Hospital, Kollund
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Carsten Bruun, MD
- Email: ryg@privathospitaletkollund.dk
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Køge, Denmark, 4600
- Recruiting
- Department of Orthopedic Surgery, Zealand University Hospital, Køge
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Leif Broeng, MD
- Phone Number: +4547323301
- Email: lbre@regionsjaelland.dk
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Nykøbing Falster, Denmark, 4800
- Recruiting
- Department of Orthopedic Surgery, Copenahegn University Hospital - Nykøbing F.
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Jörg D Adam, MD
- Phone Number: +4556518510
- Email: jdad@regionsjaelland.dk
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Næstved, Denmark, 4700
- Recruiting
- Department for Planned Orthopaedic Surgery, Næstved, Copenhagen University Hospital - Næstved, Slagelse and Ringsted
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Kim P Sperling, MD
- Phone Number: +4593571413
- Email: kpsp@regionsjaelland.dk
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Odense, Denmark, 5000/5700
- Recruiting
- Department of Orthopedic Surgery and Traumatology, Odense University Hospital and Svendborg Hospital
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Martin H Haubro, MD
- Email: Martin.Haagen.Haubro@rsyd.dk
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Randers, Denmark, 8930
- Recruiting
- Deparmtent of Orthopedic Surgery, Randers Regional Hospital
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Shahin Behzadi, MD
- Phone Number: +4561272800
- Email: shahbehz@rm.dk
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Ringsted, Denmark, 4100
- Recruiting
- Aleris Private Hospital, Ringsted
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Salar Bajalan, MD
- Phone Number: +4530620352
- Email: Salar.Bajalan@aleris.dk
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Rønne, Denmark, 3700
- Recruiting
- Department of Surgery, Copenhagen University Hospital - Bornholm
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Thor Munch-Andersen, MD
- Phone Number: +4538671891
- Email: thor.munch-andersen.01@regionh.dk
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Silkeborg, Denmark, 8600
- Recruiting
- Center for Planned Surgery, Silkeborg Regional Hospital
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Peter B Hollænder, MD
- Phone Number: +4521558580
- Email: peterlar@rm.dk
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Søborg, Denmark, 2860
- Recruiting
- Aleris Private Hospital, Søborg
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Thomas Rohde, MD, PhD
- Phone Number: +4530620352
- Email: Thomas.Rohde@aleris.dk
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Vejle, Denmark, 7100
- Recruiting
- Department of Orthopedics, Lillebaelt Hospital, Vejle
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Peter H Revald, MD
- Phone Number: +4579405166
- Email: peter.revald@rsyd.dk
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Vejle, Denmark, 7100
- Recruiting
- Mølholm Private Hospital, Vejle
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Kjeld Søballe, MD, DMSc
- Email: kjeld@soballe.com
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Viborg, Denmark, 8800
- Recruiting
- Deparmtent of Orthopedic Sugery, Viborg Regional Hospital
-
Contact:
- Armita A Abedi, MD
- Phone Number: +4551358644
- Email: armita.armina.abedi@regionh.dk
-
Contact:
- Anders Assenholt, MD
- Phone Number: +4578446687
- Email: Anders.Assenholt@rm.dk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients receiving a primary Total Hip Arthroplasty (THA) due to an acute- or sequelae of proximal femoral or acetabular fractures
Exclusion Criteria:
- Patients receiving a primary THA due to bone tumor or metastasis
- Patients receiving a primary THA due to osteoarthritis and all reasons according to the Danish Hip Arthroplasty Register (DHR) except conditions mentioned in the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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. |
Active Comparator: 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Prosthetic joint infections (PJI)
Time Frame: Within 90 days from index surgery
|
The definition of PJI is based on revision surgery. Revision surgery is defined as a new surgical intervention the first time after the primary intervention including debridement alone or in combination with complete or partial removal or exchange of the implant. The definition of PJI is based on revision surgery. Revision surgery is defined as a new surgical intervention the first time after the primary intervention including debridement alone or in combination with complete or partial removal or exchange of the implant.
|
Within 90 days from index surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Potential PJI referred to as PJI-likely
Time Frame: Within 90 days from index surgery
|
PJI-likely is defined as at least one of the two criteria:
|
Within 90 days from index surgery
|
Length of hospital stay (LOS)
Time Frame: Within 90 days from index surgery
|
LOS defined as number of postoperative overnight stays, including transferals to other departments and hospitals.
Data on LOS is acquired from DNPR.
|
Within 90 days from index surgery
|
Incidence of Thromboembolic complications incl VTE, MI, AF, stroke
Time Frame: Within 90 days from index surgery
|
VTE is defined a priori as both deep venous thromboembolisms confirmed by compression ultrasound and pulmonary embolism confirmed by spiral computed tomography (CT), ventilation-perfusion scintigraphy or pathological removal of an embolus and based on the following diagnostic ICD10 codes: I26, I80.1-I80.9,
I82.1-I82.9, or T81.7B-D.
Data will be extracted from DNPR.
|
Within 90 days from index surgery
|
Hospital-treated infections (excluding Surgical Site infections)
Time Frame: Within 90 days from index surgery
|
Any Hospital-treated infection is defined as any first-time hospital admission with a primary or secondary infection diagnosis after discharge from index THA surgery. Hospital-treated infections are identified from DNPR. The list of infections includes chronic and more rare infections, to detect possible flare-up in any possible ongoing infections. The list will exclude urinary tract infections (UTI) due to a high risk of different registration praxis registration for UTI among hospitals in Denmark. |
Within 90 days from index surgery
|
Proportion of patients with at least one dispensing for antibiotic
Time Frame: Within 90 days from index surgery
|
Community-based antibiotic use (any community-treated infection or antibiotic use after discharge) is defined as at least one dispensing after discharge from index THA surgery within 90 days for narrow- and broad-spectrum antibiotics based on the Anatomical Therapeutic Chemical classification (ATC) codes.
All antibiotics in Denmark require prescriptions from a physician.
The Danish National Health Service Prescription Database has registered all reimbursed prescriptions from all community pharmacies since 2004.
Medications are coded according to the following ATC codes: J01CE, J01CF, J01DB, J01DC, J01DD, J01DE, J01DH, J01DI, J01CR, J01CA, J01F.
J01E, J01MA ,J01AA
|
Within 90 days from index surgery
|
Proportion of patients with dispensing for acetaminophen or non-steroid anti-inflammatory drug
Time Frame: Within 90 days from index surgery
|
Prescription redeemed is defined as at least 1 prescription dispensing of any acetaminophen or NSAID within 90 days after index THA surgery.
Prescriptions of analgesics are identified using the Danish National Prescription Registry.
Information on Anatomical Classification System (ATC) codes and dispensation date will be applied to identify acetaminophen and NSAID.
Following ATC codes (including all sub codes) are included M01A (NSAIDs).
Duration of treatment will be calculated based on no. of packages and volume.
|
Within 90 days from index surgery
|
Number of patients with one or more Serious Adverse Events (SAEs)
Time Frame: Within 90 days from index surgery
|
SAEs are defined according to the ICH-GCP guidelines. SAE refers to an event involving a significant risk of death or disability of the patient (or their offspring), including, but not limited to, an event that:
|
Within 90 days from index surgery
|
Proportion of patients with a least one dispensing for opioids
Time Frame: Within 90 days from index surgery
|
Prescriptions redeemed is defined as at least 1 prescription dispensing of any opioid.
Prescriptions of analgesics will be identified through The Danish National Prescription Registry.
The registry contains information on all prescriptions redeemed by Danish residents in community pharmacies since 1995 (excluding hospital dispensaries).
Information on Anatomical Classification System (ATC) codes and dispensation date will be applied to identify opioids.
Following ATC codes (including all sub codes) are included: N01AH (opioid anesthetics), N02A (opioids), N07BC02 (methadone), and R05DA04 (codeine).
Duration of treatment will be calculated based on no. of packages and volume.
|
Within 90 days from index surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incremental cost-effectiveness
Time Frame: Within 90 days from index surgery
|
The incremental cost-effectiveness will be calculated based on the costs per patient in the two antibiotic practices. Costs related to antibiotic prophylaxis, hospital admissions and readmissions, hospital outpatient visits, visits to General practitioner and costs related to sick leave from work will be included. Data will be collected from:
|
Within 90 days from index surgery
|
Mortality rate after index surgery
Time Frame: Within 1 year from index surgery
|
1-year mortality rate is defined by date of death due to any cause after index surgery.
Data is collected from The Civil Registration System (CRS).
|
Within 1 year from index surgery
|
Incidence of Superficial incisional Surgical Site Infection
Time Frame: Within 90 days from index surgery
|
To be defined
|
Within 90 days from index surgery
|
Rate of revision after THA
Time Frame: Within 1 year from index surgery
|
Revision surgery is defined as a new surgical intervention the first time after the primary intervention including debridement alone or in combination with complete or partial removal or exchange of the implant. Revision due to any cause including PJI and aseptic loosening are included. Revision risk is recorded from DHR and DNPR. |
Within 1 year from index surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Armita A Abedi, MD, Copenhagen University Hospital, Bispebjerg Department of Orthopedic Surgery and Traumatology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ProHipQ Fracture
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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