Clinical trial

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

NCT06200402

Name

BCHIP

Description

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.

Trial arms

Trial start

2023-07-01

Estimated PCD

2023-12-01

Trial end

2025-12-30

Status

Recruiting

Treatment

Antibiotic loaded

This is the intervention for the study group. It involves the use of bone cement mixed with antibiotics (typically gentamicin or similar) in the hip prosthesis surgery. The purpose of this intervention is to assess whether the antibiotic-loaded cement reduces the incidence of postoperative infections compared to standard cement

Arms:

Intervention

Placebo

Arms:

control

Size

450

Primary endpoint

Incidence of Acute Postoperative Infections

7 days post surgery

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 450, 'type': 'ESTIMATED'}}

Updated at

2024-01-11

1 organization

1 product

1 indication

Organization

Università Vita-Salute San Raffaele

Product

Antibiotic

Indication

Hip Fractures