Clinical Trials Directory

Trials / Completed

CompletedNCT01631968

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,948 (actual)
Sponsor
Parc de Salut Mar · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECement without antibiotic.
PROCEDURECement with erytromycin and colistin.

Timeline

Start date
2007-09-01
Primary completion
2011-03-01
Completion
2012-05-01
First posted
2012-06-29
Last updated
2016-02-24

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT01631968. Inclusion in this directory is not an endorsement.