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

NCT06200402 | Unknown DMC

• 1 other identifier: BCHIP
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Femoral Fractures

Outcome Measures

Primary Outcomes (1)

• Incidence of Acute Postoperative Infections

  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.

  7 days post surgery

Study Arms (2)

Intervention

EXPERIMENTAL

(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.

Drug: Antibiotic loaded

control

PLACEBO COMPARATOR

(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.

Other: Placebo

Interventions

Antibiotic loaded DRUG

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

Intervention

Placebo OTHER

Placebo

control

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead

Study Sites (1)

Ircss Ospedale San Raffaele

Milan, Lombardy, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Proximal Femoral Fractures

Condition Hierarchy (Ancestors)

Femoral Neck Fractures; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 11, 2024
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2025
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)