drugset / Trial / NCT05164081

Dual vs. Single-Antibiotic Impregnated Cement in Hemiarthroplasty for Femoral Neck Fracture

NCT05164081

Phase 3 Active not recruiting 7000 enrolled Umeå University Region Västerbotten · collab
RandomizedCrossoverOpen-labelPrevention

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.

Timeline

Start
2022-01-01
Primary completion
2026-01-31
Completion
2027-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Clindamycin Unknown
Background Gentamicin Small molecule