NCT05164081

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for phase_3

Timeline
9mo left

Started Jan 2022

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 2022Jan 2027

First Submitted

Initial submission to the registry

December 4, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

December 4, 2021

Last Update Submit

March 9, 2026

Conditions

Femoral Neck FracturesProsthetic Infection

Keywords

femoral neck fracturehip hemiarthroplastybone cementantibioticperiprosthetic joint infectionrandomized controlled trialdual impregnated antibiotic bone cement

Outcome Measures

Primary Outcomes (1)

  • Periprosthetic joint infection

    The definition of PJI will be that the treating physicians defined presence of a PJI and started treatment (re-operation, or suppressive antibiotics, or combinations thereof).

    1 year postoperatively

Secondary Outcomes (3)

  • Any re-operation

    1 year postoperatively

  • Antibiotic suppression

    120 days and 1-year post-surgery

  • Mortality

    90-day and 1-year mortality

Other Outcomes (2)

  • The Resistance patterns of infections

    1 year postoperatively

  • Cost-effectiveness

    1 year postoperatively

Study Arms (2)

Dual antibiotic impregnated cement

EXPERIMENTAL

Patients treated with a cemented hip hemiarthroplasty using dual antibiotic loaded bone cement (gentamicin+clindamycin) COPAL G+C (Heraeus).

Combination Product: antibiotic loaded bone cement (gentamicin+clindamycin) COPAL G+C (Heraeus).

Single antibiotic impregnated cement

ACTIVE COMPARATOR

Patients treated with a cemented hip hemiarthroplasty using single antibiotic loaded bone cement (gentamicin) Paladins R+G (Heraeus) or Refobacin (Biomet).

Combination Product: antibiotic loaded bone cement (gentamicin) Paladins R+G (Heraeus) or Refobacin (Biomet).

Interventions

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

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

Single antibiotic impregnated cement
antibiotic loaded bone cement (gentamicin+clindamycin) COPAL G+C (Heraeus).COMBINATION_PRODUCT

Hospitals are cluster-randomized to either arm for 2 years and then cross-over to the other arm for another 2 years.

Dual antibiotic impregnated cement

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University Hospital

Umeå, Västerbotten County, Sweden

Location

Related Publications (3)

  • Sprowson AP, Jensen C, Chambers S, Parsons NR, Aradhyula NM, Carluke I, Inman D, Reed MR. The use of high-dose dual-impregnated antibiotic-laden cement with hemiarthroplasty for the treatment of a fracture of the hip: The Fractured Hip Infection trial. Bone Joint J. 2016 Nov;98-B(11):1534-1541. doi: 10.1302/0301-620X.98B11.34693.

    PMID: 27803231BACKGROUND

  • Agni NR, Costa ML, Achten J, O'Connor H, Png ME, Peckham N, Dutton SJ, Wallis S, Milca S, Reed M. A randomized clinical trial of low dose single antibiotic-loaded cement versus high dose dual antibiotic-loaded cement in patients receiving a hip hemiarthroplasty after fracture: A protocol for the WHiTE 8 COPAL study. Bone Jt Open. 2021 Feb;2(2):72-78. doi: 10.1302/2633-1462.22.BJO-2020-0174.

    PMID: 33630700BACKGROUND

  • Mukka S, Hailer NP, Moller M, Gordon M, Lazarinis S, Rogmark C, Ostlund O, Skoldenberg O, Wolf O; DAICY study group. Study protocol: The DAICY trial-dual versus single-antibiotic impregnated cement in primary hemiarthroplasty for femoral neck fracture-a register-based cluster-randomized crossover-controlled trial. Acta Orthop. 2022 Oct 5;93:794-800. doi: 10.2340/17453674.2022.4819.

    PMID: 36200646BACKGROUND

Related Links

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Gentamicinsgentamicin-polymethylmethacrylate beadCimetidine

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydratesGuanidinesAmidinesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sebastian Mukka, MD, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Register-based cluster-randomized cross-over controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2021

First Posted

December 20, 2021

Study Start

January 1, 2022

Primary Completion

January 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)