Comparing dual and single antibiotic cement for hip surgery in elderly patients
DAICY Trial - Dual vs. Single-Antibiotic Impregnated Cement in Hemiarthroplasty for Femoral Neck Fracture: A Register-based Cluster-randomized Cross-over Controlled Trial
This study is testing whether using a dual-antibiotic cement during hip surgery can help older patients avoid infections better than using a single-antibiotic cement.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 7000 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå, Västerbotten) |
| Trial ID | NCT05164081 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of dual-antibiotic impregnated cement versus single-antibiotic cement in reducing the risk of periprosthetic joint infection (PJI) following hemiarthroplasty for displaced femoral neck fractures in elderly patients. The study aims to determine the incidence of PJI within one year post-surgery, alongside secondary outcomes such as re-operation rates, bacteriology, and healthcare costs. Conducted in Sweden, the trial addresses a significant health issue affecting a large population of frail elderly individuals, with a focus on improving surgical outcomes and reducing complications.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 60 and above with a displaced femoral neck fracture eligible for hemiarthroplasty.
Not a fit: Patients with previous hip surgeries, pathological fractures, or sensitivities to the components of the bone cement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly lower the incidence of infections following hip surgeries, improving recovery and quality of life for elderly patients.
How similar studies have performed: Other studies have shown promising results with antibiotic-impregnated cement in reducing infection rates, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Umeå, Västerbotten
- Umeå University Hospital — Umeå, Västerbotten, Sweden (Recruiting)
Study contacts
- Principal investigator: Sebastian Mukka, MD, PhD — Umeå University
- Study coordinator: Sebastian Mukka, MD,PhD
- Email: sebastian.mukka@umu.se
- Phone: 907850000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.