Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-29 @ 7:24 AM
Study NCT ID:
NCT01631968
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2012-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003738', 'term': 'Dental Cements'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}, {'id': 'D003091', 'term': 'Colistin'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D011113', 'term': 'Polymyxins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D023181', 'term': 'Antimicrobial Cationic Peptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000089882', 'term': 'Antimicrobial Peptides'}, {'id': 'D052899', 'term': 'Pore Forming Cytotoxic Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2948}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2012-06-28', 'studyFirstSubmitQcDate': '2012-06-28', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection', 'timeFrame': 'The minimum follow-up is 12 months.', '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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infection After Primary Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '23636182', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary total knee replacement. Both genders. No age limits.\n\nExclusion Criteria:\n\n* Allergy to erythromycin or colistin. Previous infection in the knee.'}, 'identificationModule': {'nctId': 'NCT01631968', 'briefTitle': 'Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'Incidence of Infection After Total Knee Arthroplasty Using an Erythromycin and Colistin Loaded Cement or a Standard Cement', 'orgStudyIdInfo': {'id': 'ERITR-COL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cement with erytromycin and colistin', 'description': 'In this group the knee arthroplasty was fixed with cement with erythromycin and colistin.', 'interventionNames': ['Procedure: Cement with erytromycin and colistin.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cement without antibiotic', 'description': 'In this group the knee arthroplasty was fixed with standard cement, without any antibiotics.', 'interventionNames': ['Procedure: Cement without antibiotic.']}], 'interventions': [{'name': 'Cement without antibiotic.', 'type': 'PROCEDURE', 'armGroupLabels': ['Cement without antibiotic']}, {'name': 'Cement with erytromycin and colistin.', 'type': 'PROCEDURE', 'armGroupLabels': ['Cement with erytromycin and colistin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08024', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Esperanza.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Pedro Hinarejos', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}