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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ircss Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20149 | Italy |
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| ID | Term |
|---|---|
| D000092526 | Proximal Femoral Fractures |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
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|
| Placebo | Other | Placebo |
|
| D014947 |
| Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |