MedTrace Logo

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

NCT05164081 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7000

Last updated 2026-03-10

No results posted yet for this 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.

Conditions

  • Femoral Neck Fractures
  • Prosthetic Infection

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).

Sponsors & Collaborators

  • Region Västerbotten

    collaborator OTHER_GOV

  • Umeå University

    lead OTHER

Principal Investigators

  • Sebastian Mukka, MD, PhD · Umeå University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164081 on ClinicalTrials.gov