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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01631968
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Pedro Hinarejos, Parc de Salut Mar

Tracking Information
First Submitted Date  ICMJE June 28, 2012
First Posted Date  ICMJE June 29, 2012
Last Update Posted Date February 24, 2016
Study Start Date  ICMJE September 2007
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Official Title  ICMJE Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infection After Primary Total Knee Arthroplasty
Intervention  ICMJE
  • Procedure: Cement without antibiotic.
  • Procedure: Cement with erytromycin and colistin.
Study Arms  ICMJE
  • Experimental: Cement with erytromycin and colistin
    In this group the knee arthroplasty was fixed with cement with erythromycin and colistin.
    Intervention: 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.
    Intervention: Procedure: Cement without antibiotic.
Publications * Hinarejos P, Guirro P, Leal J, Montserrat F, Pelfort X, Sorli ML, Horcajada JP, Puig L. The use of erythromycin and colistin-loaded cement in total knee arthroplasty does not reduce the incidence of infection: a prospective randomized study in 3000 knees. J Bone Joint Surg Am. 2013 May 1;95(9):769-74. doi: 10.2106/JBJS.L.00901.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2012)
2948
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to erythromycin or colistin. Previous infection in the knee.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01631968
Other Study ID Numbers  ICMJE ERITR-COL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pedro Hinarejos, Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Parc de Salut Mar
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP