Antibiotic-Loaded Cement Versus Non-Antibiotic-Loaded Cement in Hip Prosthesis Surgery for Proximal Femur Fractures

Antibiotic-Loaded Cement Versus Non-Antibiotic-Loaded Cement in Hip Prosthesis Surgery for Proximal Femur Fractures: A Prospective, Randomized, Single-Center, Blinded Study

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, assessing infection incidence, implant stability, and associated costs. This randomized, blinded study is conducted by IRCCS Ospedale San Raffaele.

Inclusion Criteria:

• 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 Criteria:

• 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.