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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infection After Primary Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Esperanza.

Barcelona, 08024, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cement without antibiotic.

Procedure

Cement with erytromycin and colistin.

Procedure

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2012
First posted: Jun 29, 2012
Registry last updated: Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.