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Dual vs. Single-Antibiotic Impregnated Cement in Hemiarthroplasty for Femoral Neck Fracture
Sponsor: Umeå University
Summary
Rational for conducting the study: Periprosthetic joint infection (PJI) is the most feared complication following prosthetic replacement of the hip joint and is associated with increased mortality, morbidity and economic burden. The aim of the trial is to investigate whether the risk of periprosthetic joint infection after treatment with hemiarthroplasty performed due to femoral neck fracture is reduced after the use of dual-impregnated antibiotic loaded cement. The primary outcome variable is the incidence of periprosthetic joint infection within one year after the index procedure. Secondary outcome variables include the occurrence of re-operations for any reason, bacteriology, antibiotic treatment, mortality and health care costs.
Official title: DAICY Trial - Dual vs. Single-Antibiotic Impregnated Cement in Hemiarthroplasty for Femoral Neck Fracture: A Register-based Cluster-randomized Cross-over Controlled Trial
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
7000
Start Date
2022-01-01
Completion Date
2027-01-31
Last Updated
2026-03-10
Healthy Volunteers
No
Interventions
antibiotic loaded bone cement (gentamicin+clindamycin) COPAL G+C (Heraeus).
Hospitals are cluster-randomized to either arm for 2 years and then cross-over to the other arm for another 2 years.
antibiotic loaded bone cement (gentamicin) Paladins R+G (Heraeus) or Refobacin (Biomet).
antibiotic loaded bone cement (gentamicin) Paladins R+G (Heraeus) or Refobacin (Biomet).
Locations (1)
Umeå University Hospital
Umeå, Västerbotten County, Sweden