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

Infection After Primary Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631968
• Other study ID #: ERITR-COL
• Status: Completed
• Phase: N/A
• First received: June 28, 2012
• Last updated: February 23, 2016
• Start date: September 2007
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2948
• Est. completion date: May 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Infection After Primary Total Knee Arthroplasty

Intervention

Procedure:
• Cement without antibiotic.

• Cement with erytromycin and colistin.

Locations

Country	Name	City	State
Spain	Hospital de la Esperanza.	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection	Presence or absence of infection, according to the Center for Disease Control's criteria. The infection cases are classified as superficial of deep infection.	The minimum follow-up is 12 months.	No