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ACTIVE NOT RECRUITING
NCT05164081
PHASE3

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

Sponsor: Umeå University

View on ClinicalTrials.gov

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

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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