Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA
Key facts
- Who runs it
- Soren Overgaard
- Where
- Denmark36 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 20,000 people enrolled
- Started
- 1 Sept 2022
- Ended
- 1 Sept 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Antibiotic dosage practice
- Record updated
- 8 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- All patients receiving a primary Total Hip Arthroplasty (THA) due to primary and secondary causes of osteoarthritis
Who cannot take part
- Patients receiving a primary THA due to either acute or sequelae of proximal femoral or acetabular fractures
- Patients receiving a primary THA due to bone tumor or metastasis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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 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.
The 2 groups in the trial
- Treatment A, Single-dose practiceTreatment being tested
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.
Treatment: Antibiotic dosage practice
- Treatment B, Multiple-dose practiceExisting treatment, for comparison
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.
Treatment: Antibiotic dosage practice
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 8 July 2026