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

February 23, 2016 updated by: Pedro Hinarejos, Parc de Salut Mar
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2948

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08024
        • Hospital de la Esperanza.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The minimum follow-up is 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERITR-COL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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