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Clinical Trials in Sweden / NCT05164081
Active, not recruiting Phase 3

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

NCT05164081 · tracked via the Priya Life Science Sweden tracker
Sponsor
Umeå University
Phase
Phase 3
Started
2022-01-01
Last updated
2026-03-10

Condition(s) studied

Femoral Neck FracturesProsthetic Infection

Investigational drug(s) / intervention(s)

antibiotic loaded bone cement (gentamicin+clindamycin) COPAL G+C (Heraeus).antibiotic loaded bone cement (gentamicin) Paladins R+G (Heraeus) or Refobacin (Biomet).

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).

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥60 years * Diagnosis: displaced femoral neck fracture type AO 31-B2 or B3/Garden type 3 or 4 * Eligible for HA according to local guidelines and routines Exclusion Criteria: * Previous inclusion of contralateral hip in the present study * Pathological or stress fracture of the femoral neck, or fracture adjacent to a previous ipsilateral hip implant * Unavailability of both interventions for a study participant (e.g., sensitivity to any of the components in the bone cement) * Patients that have actively marked their hospital charts with an added privacy notice

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Umeå University Hospital Umeå Västerbotten County

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Other trials for the same condition

Functional Outcome After ORIF or Arthroplasty for Femoral Neck Fracture Recruiting
Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05164081 on ClinicalTrials.gov ↗ ← All trials in Sweden