Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement

Not Applicable

Completed

• Conditions: Infection After Primary Total Knee Arthroplasty
• Interventions: Procedure: Cement without antibiotic.; Procedure: Cement with erytromycin and colistin.

• Registration Number: NCT01631968
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2011-03
• Study Completion: 2012-05
• Status Verified: 2012-06
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2948

Inclusion Criteria

• Primary total knee replacement. Both genders. No age limits.

Exclusion Criteria

• Allergy to erythromycin or colistin. Previous infection in the knee.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cement without antibiotic	Cement without antibiotic.	In this group the knee arthroplasty was fixed with standard cement, without any antibiotics.
Cement with erytromycin and colistin	Cement with erytromycin and colistin.	In this group the knee arthroplasty was fixed with cement with erythromycin and colistin.

Primary Outcome Measures

Name	Time	Method
Infection	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.

Trial Locations

Locations (1)

Hospital de la Esperanza.; 🇪🇸 Barcelona, Spain