Back to resultsIncidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Primary Purpose
Infection After Primary Total Knee Arthroplasty
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cement without antibiotic.
Cement with erytromycin and colistin.
Sponsored by
About this trial
This is an interventional treatment trial for Infection After Primary Total Knee Arthroplasty
Eligibility Criteria
Inclusion Criteria:
- Primary total knee replacement. Both genders. No age limits.
Exclusion Criteria:
- Allergy to erythromycin or colistin. Previous infection in the knee.
Sites / Locations
- Hospital de la Esperanza.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cement with erytromycin and colistin
Cement without antibiotic
Arm Description
In this group the knee arthroplasty was fixed with cement with erythromycin and colistin.
In this group the knee arthroplasty was fixed with standard cement, without any antibiotics.
Outcomes
Primary Outcome Measures
Infection
Presence or absence of infection, according to the Center for Disease Control's criteria. The infection cases are classified as superficial of deep infection.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01631968
Brief Title
Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Official Title
Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection After Primary Total Knee Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2948 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cement with erytromycin and colistin
Arm Type
Experimental
Arm Description
In this group the knee arthroplasty was fixed with cement with erythromycin and colistin.
Arm Title
Cement without antibiotic
Arm Type
Placebo Comparator
Arm Description
In this group the knee arthroplasty was fixed with standard cement, without any antibiotics.
Intervention Type
Procedure
Intervention Name(s)
Cement without antibiotic.
Intervention Type
Procedure
Intervention Name(s)
Cement with erytromycin and colistin.
Primary Outcome Measure Information:
Title
Infection
Description
Presence or absence of infection, according to the Center for Disease Control's criteria. The infection cases are classified as superficial of deep infection.
Time Frame
The minimum follow-up is 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary total knee replacement. Both genders. No age limits.
Exclusion Criteria:
Allergy to erythromycin or colistin. Previous infection in the knee.
Facility Information:
Facility Name
Hospital de la Esperanza.
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23636182
Citation
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.
Results Reference
derived
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Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
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