Status:
UNKNOWN
Antibiotic-Loaded Cement Versus Non-Antibiotic-Loaded Cement in Hip Prosthesis Surgery for Proximal Femur Fractures
Lead Sponsor:
Università Vita-Salute San Raffaele
Conditions:
Proximal Femoral Fractures
Eligibility:
All Genders
65-100 years
Phase:
NA
Brief Summary
The study aims to determine if antibiotic-loaded cement reduces post-surgery infection rates compared to non-antibiotic cement. The trial involves 450 elderly patients with specific hip fractures, ass...
Eligibility Criteria
Inclusion
- Patients must be older than 65 years
- Fracture Type: The study includes patients with medial femoral neck fractures classified as AO type B1, B2, and B3, indicating specific types of hip fractures.
- Surgical Indication: Patients should have an indication for prosthetic hip surgery.
- Informed Consent: Patients must provide signed informed consent to participate in the study
Exclusion
- Fracture Type: Exclusion of patients with trochanteric region fractures and femoral head fractures (AO classification types A and C), periprosthetic fractures, patients with multiple traumas or multiple fractures.
- Blood Test Anomalies: Patients with pre-operative blood test anomalies, such as ionic disorders and hemoglobin levels lower than 8 g/dL.
- Renal Insufficiency: Patients with renal insufficiency.
- Active Infections: Exclusion of patients with active infections or suspected/confirmed hypersensitivity or allergy to gentamicin, history of toxicity or reaction to aminoglycosides.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06200402
Start Date
July 1 2023
End Date
December 30 2025
Last Update
January 11 2024
Active Locations (1)
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1
Ircss Ospedale San Raffaele
Milan, Lombardy, Italy, 20149