Study Summary
This trial is testing whether a 7-day course of an oral, prophylactic antibiotic can reduce the incidence of periprosthetic joint infection and wound complications following primary total hip and knee arthroplasty in a high-risk patient population.
Eligible Conditions
- Prosthetic Joint Infections
- Chronic Kidney Disease
- Tobacco Use
- Overweight or Obesity
- Methicillin-susceptible Staphylococcus aureus Colonization
- Methicillin-resistant Staphylococcus aureus
- Diabetes
- Inflammatory Diseases
- Autoimmune Diseases
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Within 1-year of primary hip or knee arthroplasty
Within 1-year of primary hip or knee arthroplasty
Communicable Diseases
Day 90
Wound complication
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Group B - no additional antibiotic
1 of 2
Group A - antibiotic group
1 of 2
Active Control
956 Total Participants · 2 Treatment Groups
Primary Treatment: Group A - antibiotic group · No Placebo Group · Phase 4
Group B - no additional antibioticNoIntervention Group · 1 Intervention: Group B - no additional antibiotic · Intervention Types:
Group A - antibiotic groupActiveComparator Group · 2 Interventions: Cephalexin Oral Tablet, Doxycycline Hyclate · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 1-year of primary hip or knee arthroplasty
Who is running the clinical trial?
University of IowaLead Sponsor
410 Previous Clinical Trials
874,973 Total Patients Enrolled
Nicholas Bedard, MDPrincipal InvestigatorUniversity of Iowa Hospitals & Clinics
Jacob Elkins, MDPrincipal InvestigatorUniversity of Iowa Hospitals & Clinics
Eligibility Criteria
Age 18 - 99 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are between the ages of 18-99.
You are undergoing elective, primary total hip or total knee arthroplasty.
You have one or more of the following high risk criteria: BMI > 35 kg/m^2, diagnosis of diabetes, active tobacco user, chronic kidney disease (estimated glomerular filtration < 60 mL/min/1.
References
- Inabathula, Avinash, Julian E. Dilley, Mary Ziemba-Davis, Lucian C. Warth, Khalid A. Azzam, Philip H. Ireland, and R. Michael Meneghini. 2018. “Extended Oral Antibiotic Prophylaxis in High-risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-day Infection Rate”. Journal of Bone and Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.17.01485.
- Li, Bingyun, and Thomas J. Webster. 2017. “Bacteria Antibiotic Resistance: New Challenges and Opportunities for Implant-associated Orthopedic Infections”. Journal of Orthopaedic Research. Wiley. doi:10.1002/jor.23656.
- Kurtz, Steven M., Edmund Lau, Heather Watson, Jordana K. Schmier, and Javad Parvizi. 2012. “Economic Burden of Periprosthetic Joint Infection in the United States”. The Journal of Arthroplasty. Elsevier BV. doi:10.1016/j.arth.2012.02.022.
- Jacob M. Elkins 2020. "Antibiotic Prophylaxis in High-Risk Arthroplasty Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04297592.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments