Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
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|ClinicalTrials.gov Identifier: NCT01631968|
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infection After Primary Total Knee Arthroplasty||Procedure: Cement without antibiotic. Procedure: Cement with erytromycin and colistin.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2948 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||May 2012|
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.
- Infection [ Time Frame: The minimum follow-up is 12 months. ]Presence or absence of infection, according to the Center for Disease Control's criteria. The infection cases are classified as superficial of deep infection.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631968
|Hospital de la Esperanza.|
|Barcelona, Spain, 08024|