Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 2011
Interventions
- Procedure: Cement without antibiotic.
- Procedure: Cement with erytromycin and colistin.
Arms, Groups and Cohorts
- Experimental: Cement with erytromycin and colistin
- In this group the knee arthroplasty was fixed with cement with erythromycin and colistin.
- Placebo Comparator: Cement without antibiotic
- In this group the knee arthroplasty was fixed with standard cement, without any antibiotics.
Clinical Trial Outcome Measures
Primary Measures
- 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.
Participating in This Clinical Trial
Inclusion Criteria
- Primary total knee replacement. Both genders. No age limits. Exclusion Criteria:
- Allergy to erythromycin or colistin. Previous infection in the knee.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Parc de Salut Mar
- Provider of Information About this Clinical Study
- Principal Investigator: Pedro Hinarejos, PhD – Parc de Salut Mar
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