Comparing antibiotic-loaded cement to regular cement in hip surgery for fractures
Antibiotic-Loaded Cement Versus Non-Antibiotic-Loaded Cement in Hip Prosthesis Surgery for Proximal Femur Fractures: A Prospective, Randomized, Single-Center, Blinded Study
This study tests if using antibiotic-loaded cement during hip surgery can help prevent infections in older patients with certain types of hip fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 65 Years to 100 Years |
| Sex | All |
| Sponsor | Università Vita-Salute San Raffaele Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Trial ID | NCT06200402 on ClinicalTrials.gov |
What this trial studies
This study investigates whether using antibiotic-loaded cement during hip prosthesis surgery can lower the risk of post-surgery infections compared to non-antibiotic cement. It involves 450 elderly patients over 65 years old with specific types of proximal femur fractures. The trial is randomized and blinded, focusing on infection rates, implant stability, and associated costs. Conducted by IRCCS Ospedale San Raffaele, the study aims to provide insights into improving surgical outcomes for hip fractures.
Who should consider this trial
Good fit: Ideal candidates are elderly patients over 65 years with specific medial femoral neck fractures requiring hip prosthesis surgery.
Not a fit: Patients with trochanteric region fractures, active infections, or renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce post-surgery infection rates in elderly patients undergoing hip surgery.
How similar studies have performed: Other studies have shown promising results with antibiotic-loaded materials in reducing infection rates, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan, Lombardy
- Ircss Ospedale San Raffaele — Milan, Lombardy, Italy (Recruiting)
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.