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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Magi Farre, Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01631968
First received: June 28, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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. ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

No publications provided by Parc de Salut Mar

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Magi Farre, Pedro Hinarejos, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01631968     History of Changes
Other Study ID Numbers: ERITR-COL
Study First Received: June 28, 2012
Last Updated: June 28, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Anti-Bacterial Agents
Colistin
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014