Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Prospective randomized study in cemented primary total knee arthroplasty. In one group the cement used was standard cement, without any antibiotics and in the other group the cement used was loaded with 0.5 g of erythromycin and 3 million units of colistin in 40 g of cement. In all cases intravenous antibiotics prophylaxis against infection was used. In both groups the cement was mechanically mixed in a vacuum. One deep drain tube was placed for 24 hours in all cases. The main variable was the presence of infection according to the Center of Disease Control criteria with a minimum of 12 months follow-up.
Infection After Primary Total Knee Arthroplasty
Procedure: Cement without antibiotic.
Procedure: Cement with erytromycin and colistin.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement|
- Infection [ Time Frame: The minimum follow-up is 12 months. ] [ Designated as safety issue: No ]Presence or absence of infection, according to the Center for Disease Control's criteria. The infection cases are classified as superficial of deep infection.
|Study Start Date:||September 2007|
|Study Completion Date:||May 2012|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: Cement with erytromycin and colistin
In this group the knee arthroplasty was fixed with cement with erythromycin and colistin.
|Procedure: Cement with erytromycin and colistin.|
Placebo Comparator: Cement without antibiotic
In this group the knee arthroplasty was fixed with standard cement, without any antibiotics.
|Procedure: Cement without antibiotic.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631968
|Hospital de la Esperanza.|
|Barcelona, Spain, 08024|