Fracture of HipProHipQ-FNCT05530174
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture
A study testing Antibiotic dosage practice in people with Fracture of Hip and Total Hip Arthroplasty, run by Soren Overgaard at 36 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Hip, Total Hip Arthroplasty, Prosthetic-joint Infection
- What is being tested?
- Antibiotic dosage practice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 36 sitesDenmark
- Study dates
- 1 Sep 2022to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients receiving a primary Total Hip Arthroplasty (THA) due to an acute- or sequelae of proximal femoral or acetabular fractures
Who cannot join
- 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
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Denmark36 sites
Department of Orthopedic Surgery, Aabenraa and Sønderborg, Hospital of Southern Jutland
Aabenraa, 6200/6400
Capio Private Hospital, Aalborg
Aalborg, 9000
Department of Orthopedic Surgery, Aalborg, Aalborg University Hospital
Aalborg, 9000
Aleris Private Hospital, Aarhus
Aarhus, 8200
Deaprtment of Orthopaedic Surgery, Aarhus University Hospital
Aarhus, 8200
Capio Private Hospital, Aarhus
Aarhus C, 8000
Capio Private Hospital, Gildhøj
Brøndby, 2605
Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital - Bispebjerg and Frederiksberg
Copenhagen NV, 2400
Adeas Private Hospital, Parken
Copenhagen Ø, 2100
Department of Orthopedic Surgery, Esbjerg, Hospital of South West Jutland
Esbjerg, 6700
Department of Orthopedic Surgery, Farsø, Aalborg University Hospital
Farsø, 9640
CPH Private Hospital
Farum, 3520
Department of Orthopedic Surgery, Frederikshavn, Aalborg University Hospital
Frederikshavn, 9900
Department of Orthopedic Surgery, Grindsted, Hospital of South West Jutland
Grindsted, 7200
Capio Private Hospital, Hellerup and Odense
Hellerup, 2900/5000
Department of Orthopaedic Surgery, Gentofte, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, 2900
Department of Orthopaedic Surgery, Herlev, Copenhagen University Hospital - Herlev and Gentofte
Herlev, 2730
Department of Orthopedic Surgery, Gødstrup Regional Hospital
Herning, 7400
Department of Orthopedic Surgery, Hillerød, Copenhagen University Hospital - North Zealand
Hillerød, 3400
Department of Orthopedic Surgery, Copenhagen University Hospital - Holbæk
Holbæk, 4300
Department of Orthopedic Surgery, Horsens Regional Hospital, Denmark
Horsens, 8700
Department of Orthopedic Surgery, Hvidovre, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, 2650
Department of Orthopedic Surgery, Zealand University Hospital, Køge
Køge, 4600
Acure Private Hospital
Kongens Lyngby, 2800
Kollund Private Hospital, Kollund
Kruså, 6340
Department for Planned Orthopaedic Surgery, Næstved, Copenhagen University Hospital - Næstved, Slagelse and Ringsted
Næstved, 4700
Department of Orthopedic Surgery, Copenahegn University Hospital - Nykøbing F.
Nykøbing Falster, 4800
Department of Orthopedic Surgery and Traumatology, Odense University Hospital and Svendborg Hospital
Odense, 5000/5700
Deparmtent of Orthopedic Surgery, Randers Regional Hospital
Randers, 8930
Aleris Private Hospital, Ringsted
Ringsted, 4100
Department of Surgery, Copenhagen University Hospital - Bornholm
Rønne, 3700
Center for Planned Surgery, Silkeborg Regional Hospital
Silkeborg, 8600
Aleris Private Hospital, Søborg
Søborg, 2860
Department of Orthopedics, Lillebaelt Hospital, Vejle
Vejle, 7100
Mølholm Private Hospital, Vejle
Vejle, 7100
Deparmtent of Orthopedic Sugery, Viborg Regional Hospital
Viborg, 8800
About this study
Official title: 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.
Read the 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.
- Being tested
- Antibiotic dosage practice
- Keywords
- Antibiotic Prophylaxis, Hip Fracture, Acetabular Fracture, Total Hip Replacement, Total Hip Arthroplasty, Prosthetic Joint Infection, PJI, Cluster Randomized Controlled Trial, Randomized Controlled Trial, RCT, THA
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic dosage practiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A, Single-dose practice | Experimental | 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. Receives: Other: Antibiotic dosage practice |
| Treatment B, Multiple-dose practice | Active comparator | 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. Receives: Other: Antibiotic dosage practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Prosthetic joint infections (PJI)
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.
- Two or more intraoperative deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples
- One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated
- A PJI when an indication of deep infection is reported to The Danish Hip Arthroplasty Registry (DHR) by the surgeon upon revision surgery
Measured: Within 90 days from index surgery
Secondary outcomes (9)
Number of patients with one or more Serious Adverse Events (SAEs)
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:
- results in death
- is life-threatening - in the investigator's opinion the patient was in immediate risk of death from the adverse event when it appeared
- requires hospitalization or prolongs existing hospitalization
- results in permanent or significant disability
- is a congenital anomaly SAEs are recorded from The Danish National Patient Registry (DNPR).
Measured: Within 90 days from index surgery
Incidence of Potential PJI referred to as PJI-likely
PJI-likely is defined as at least one of the two criteria:
- One single intraoperatively obtained positive culture (aspiration fluid OR tissue biopsy) regardless of microorganism
- One single positive culture obtained from aspiration of synovial fluid regardless of microorganism AND any antibiotic prescriptions (ATC category J01) redeemed
Measured: Within 90 days from index surgery
Length of hospital stay (LOS)
LOS defined as number of postoperative overnight stays, including transferals to other departments and hospitals. Data on LOS is acquired from DNPR.
Measured: Within 90 days from index surgery
Incidence of Major Adverse Cardiovascular Events (MACE)
A MACE is defined a priori to include thromboembolic complications including venous thromboembolism, myocardial infarction, atrial fibrillation and stroke based on the diagnostic ICD10 codes listed in Appendix B. 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.
Measured: Within 90 days from index surgery
Hospital-treated infections (excluding Surgical Site infections)
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.
Measured: Within 90 days from index surgery
Proportion of patients with at least one dispensing for antibiotic
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
Measured: Within 90 days from index surgery
Opioid use
Prescriptions will be identified using NPR. The following ATC codes (including all subcodes) are included: N01AH (opioid anesthetics), N02A (opioids), N07BC02 (methadone), and R05DA04 (codeine). We defined opioid users as patients who redeemed two opioid prescriptions within six months prior to THA surgery. Conversely, patients who did not redeem two or more opioid prescriptions within this timeframe were classified as opioid naïve. For opioid naïve patients, opioid use post-THA is defined as the redemption of two opioid prescriptions within 90 days following surgery. We assert that two separate redeemed prescriptions confirm actual medication use. We will calculate the treatment dosage based on the number of packages and volume redeemed within 90 days post-surgery. To investigate dosages, all doses will be converted to morphine milligram equivalents using a conversion factor specific to the type of opioid.
Measured: Within 90 days from index surgery
Use of acetaminophen or non-steroidal anti-inflammatory drugs
Patients who received at least one prescription for acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) following THA surgery. Prescriptions of analgesics will be identified using NPR (41). All analgesics in Denmark except 10-tablet packages of acetaminophen / ibuprofen of dose 200mg ibuprofen require prescriptions from a physician. Following ATC codes (including all subcodes) are included M01A (NSAIDs) and N02BE01 (paracetamol). Duration of treatment will be calculated based on number of packages and volume. Since there is no clear definition of acetaminophen or non-steroidal anti-inflammatory users, we define these users as patients who redeemed two prescriptions within 6 months before THA.
Measured: Within 90 days from index surgery
Any revision after THA
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 any implants. Rate of revision is defined as revision due to any cause within 90 days from primary THA surgery. Any revision will be recorded from DHR and DNPR.
Measured: Within 90 days from index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Sep 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The Pro-Hip-Quality Trial is a Cluster Randomized Trial with an embedded Cross-Over Design where each clinical center (C: 1, 2, 3, …., 36 individual sites) will be running a specific intervention (i.e. single- or multiple-dose antibiotics) throughout 12 months, and the subsequent year the clinical department will automatically switch to the opposite intervention (i.e. multiple- or single-dose antibiotics).
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soren Overgaard
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University Hospital Bispebjerg and Frederiksberg, Odense University Hospital, Aarhus University Hospital, University of Aarhus, Sygehus Lillebaelt
- Responsible party
- Sponsor-investigator, Soren Overgaard, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Armita A Abedi, MD, Principal investigator, Copenhagen University Hospital, Bispebjerg Department of Orthopedic Surgery and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530174
- Sponsor's protocol ID
- ProHipQ Fracture
- Acronym
- ProHipQ-F
- Status last verified
- Mar 2025
- First submitted
- 30 Aug 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), will be provided to anyone who wishes to access the data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05530174
- Acronym / sponsor ID
- ProHipQ-F / ProHipQ Fracture
- Keywords
- Antibiotic Prophylaxis, Hip Fracture, Acetabular Fracture, Total Hip Replacement, Total Hip Arthroplasty, Prosthetic Joint Infection, PJI, Cluster Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Soren OvergaardUniversity, hospital or other
- Collaborators
- University of Copenhagen, University Hospital Bispebjerg and Frederiksberg, Odense University Hospital, Aarhus University Hospital, University of Aarhus, Sygehus Lillebaelt
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Pro-Hip-Quality Trial is a Cluster Randomized Trial with an embedded Cross-Over Design where each clinical center (C: 1, 2, 3, …., 36 individual sites) will be running a specific intervention (i.e. single- or multiple-dose antibiotics) throughout 12 months, and the subsequent year the clinical department will automatically switch to the opposite intervention (i.e. multiple- or single-dose antibiotics).
| Arm | Type | Receives |
|---|---|---|
| Treatment A, Single-dose practice | Experimental | Other: Antibiotic dosage practiceOne 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. |
| Treatment B, Multiple-dose practice | Active comparator | Other: Antibiotic dosage practiceOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients receiving a primary Total Hip Arthroplasty (THA) due to an acute- or sequelae of proximal femoral or acetabular fractures
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic dosage practicePatient 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. | Other | Treatment A, Single-dose practice, Treatment B, Multiple-dose practice |
Primary outcome
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. 1. Two or more intraoperative deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples 2. One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated 3. A PJI when an indication of deep infection is reported to The Danish Hip Arthroplasty Registry (DHR) by the surgeon upon revision surgery
9 secondary outcomes
Number of patients with one or more Serious Adverse Events (SAEs)
Time frame: Within 90 days from index surgery
Incidence of Potential PJI referred to as PJI-likely
Time frame: Within 90 days from index surgery
Length of hospital stay (LOS)
Time frame: Within 90 days from index surgery
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: Within 90 days from index surgery
Hospital-treated infections (excluding Surgical Site infections)
Time frame: Within 90 days from index surgery
Proportion of patients with at least one dispensing for antibiotic
Time frame: Within 90 days from index surgery
Opioid use
Time frame: Within 90 days from index surgery
Use of acetaminophen or non-steroidal anti-inflammatory drugs
Time frame: Within 90 days from index surgery
Any revision after THA
Time frame: Within 90 days from index surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Yes. Access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), will be provided to anyone who wishes to access the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armita A Abedi, MD principal investigator
Copenhagen University Hospital, Bispebjerg Department of Orthopedic Surgery and Traumatology
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic dosage practice in people with Fracture of Hip and Total Hip Arthroplasty, run by Soren Overgaard at 36 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Prosthetic joint infections (PJI) (time frame: Within 90 days from index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.