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

Parc de Salut Mar

Status: Completed

Conditions: Infection After Primary Total Knee Arthroplasty

Treatments: Procedure: Cement without antibiotic.; Procedure: Cement with erytromycin and colistin.

Study type: Interventional

Funder types: Other

Identifiers

NCT01631968

ERITR-COL

Details and patient eligibility

About

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.

Enrollment: 2,948 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,948 participants in 2 patient groups, including a placebo group

Cement with erytromycin and colistin

Experimental group

Description:

In this group the knee arthroplasty was fixed with cement with erythromycin and colistin.

Treatment:

Procedure: Cement with erytromycin and colistin.

Cement without antibiotic

Placebo Comparator group

Description:

In this group the knee arthroplasty was fixed with standard cement, without any antibiotics.

Treatment:

Procedure: Cement without antibiotic.