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

Università Vita-Salute San Raffaele

Status: Enrolling

Conditions: Proximal Femoral Fractures

Treatments: Other: Placebo; Drug: Antibiotic loaded

Study type: Interventional

Funder types: Other

Identifiers

NCT06200402

BCHIP

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

(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.

Treatment:

Drug: Antibiotic loaded

control

Placebo Comparator group

Description:

(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.

Treatment:

Other: Placebo