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

NCT06200402 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2024-01-11

No results posted yet for this study

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

Interventions

DRUG

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

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Università Vita-Salute San Raffaele

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2023-12-01
Completion
2025-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06200402 on ClinicalTrials.gov