DAICY trial – Dual vs. Single-Antibiotic Impregnated Cement in Hemiarthroplasty for Femoral Neck Fracture: A Register-based and cluster-randomized cross-over trial

Rational for conducting the study: The most commonly used treatment of displaced femoral neck fracture in the elderly is hemiarthroplasty which provides a reliable clinical result.

Deep periprosthetic joint infection (PJI) is a severe complication associated with an increased morality and often leads to major and repeated reoperations. PJI has been reported to occur in 2-4% of hemiarthroplasties after fracture.

The aim of the trial is to investigate whether the risk of PJI is reduced after the use of dual impregnated antibiotic laden bone cement.Study design: Register-based, cluster randomized controlled trial.Population: Number of patients: 7,312.

Inclusion criteria: Patients aged ≥60-year, with a displaced femoral neck fracture and eligible for hemiarthroplasty according to local guidelines. Exclusion criteria: Previous inclusion of contralateral hip.

Pathological or stress fracture of the femoral neck or fracture adjacent to a previous ipsilateral hip implant.Intervention: Dual-impregnated antibiotic laden bone cement.Control: Single-impregnated antibiotic laden bone cement.Outcome: Primary outcome variable is the incidence of PJI within one year.

Secondary outcome variables include the occurrence of re-operations for any reason, mortality,and health care costs.

Future benefit and clinical application: A reduction of PJI could decrease the morbidity and mortality of this elderly population and reduce the need for reoperations and antibiotic treatment.