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

This study has been completed.
Information provided by (Responsible Party):
Pedro Hinarejos, Parc de Salut Mar Identifier:
First received: June 28, 2012
Last updated: February 23, 2016
Last verified: June 2012
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.

Condition Intervention
Infection After Primary Total Knee Arthroplasty
Procedure: Cement without antibiotic.
Procedure: Cement with erytromycin and colistin.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement

Resource links provided by NLM:

Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • 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.

Enrollment: 2948
Study Start Date: September 2007
Study Completion Date: May 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cement with erytromycin and colistin
In this group the knee arthroplasty was fixed with cement with erythromycin and colistin.
Procedure: Cement with erytromycin and colistin.
Placebo Comparator: Cement without antibiotic
In this group the knee arthroplasty was fixed with standard cement, without any antibiotics.
Procedure: Cement without antibiotic.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to erythromycin or colistin. Previous infection in the knee.
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Please refer to this study by its identifier: NCT01631968

Hospital de la Esperanza.
Barcelona, Spain, 08024
Sponsors and Collaborators
Parc de Salut Mar
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pedro Hinarejos, PhD, Parc de Salut Mar Identifier: NCT01631968     History of Changes
Other Study ID Numbers: ERITR-COL
Study First Received: June 28, 2012
Last Updated: February 23, 2016

Additional relevant MeSH terms:
Communicable Diseases
Anti-Bacterial Agents
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017