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

Not Applicable

Recruiting

• Conditions: Proximal Femoral Fractures
• Interventions: Other: Placebo; Drug: Antibiotic loaded

• Registration Number: NCT06200402
• Lead Sponsor: Università Vita-Salute San Raffaele

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study First Submitted: 2023-12-27
• Study First Submitted QC: 2023-12-27
• Last Update Submitted: 2023-12-27
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Placebo	(Non-Antibiotic-Loaded Cement Arm): Participants in this group will undergo hip prosthesis surgery using non-antibiotic-loaded cement. This arm serves as the control to compare the outcomes with the antibiotic-loaded cement group.
Intervention	Antibiotic loaded	(Antibiotic-Loaded Cement Arm): This group will receive hip prosthesis surgery using antibiotic-loaded cement. The use of antibiotic-loaded cement is intended to investigate its effectiveness in reducing the rate of acute postoperative infections.

Primary Outcome Measures

Name	Time	Method
Incidence of Acute Postoperative Infections	7 days post surgery	This outcome measure focuses on the rate of acute infections occurring postoperatively in patients undergoing hip prosthesis surgery. The study will compare the incidence of such infections between the two groups: one receiving antibiotic-loaded cement and the other receiving non-antibiotic-loaded cement. An acute infection is typically defined based on clinical signs, laboratory markers of infection (like elevated C-reactive protein levels, white blood cell count, etc.), and the need for any additional interventions or treatments due to infection.

Trial Locations

Locations (1)

Ircss Ospedale San Raffaele; 🇮🇹 Milan, Lombardy, Italy