Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patien… (NCT05530551) | Clinical Trial Compass
CompletedNot Applicable
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA
Denmark20,000 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared giving a single dose of prophylactic antibiotics versus multiple doses before and after total hip replacement to prevent prosthetic joint infection — can you tell me which approach you use in your practice and whether the results of this study have influenced your decision?
2Since this trial has already been completed, have the findings shown any meaningful difference in infection rates between the single-dose and multiple-dose antibiotic approaches, and how might those results apply to my specific situation?
3Prosthetic joint infection is listed as the primary outcome being measured — how serious is that risk for someone like me undergoing a total hip replacement for osteoarthritis, and what signs should I watch for after surgery?
4Given that this trial is now complete and was studying antibiotic protocols rather than a new device or drug, does the standard of care at this hospital already reflect the best available evidence on preventing infection after hip replacement?
5Are there any personal factors — like my age, weight, immune health, or other medications — that would affect which antibiotic prophylaxis approach is safest and most appropriate for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.