Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-02 @ 6:35 AM
Study NCT ID:
NCT01085669
Status:
UNKNOWN
Last Update Posted:
2010-03-12
First Post:
2010-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infection Rate of Vertical Expandable Prosthetic Titanium Rib Implants (VEPTR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-11', 'studyFirstSubmitDate': '2010-03-11', 'studyFirstSubmitQcDate': '2010-03-11', 'lastUpdatePostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection rate of VEPTR Implants', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infection rate of VEPTR-Implants', 'VEPTR. Vertical Expandable', 'Prosthetic Titanium Rib'], 'conditions': ['Infection']}, 'descriptionModule': {'briefSummary': 'The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities.', 'detailedDescription': "Spinal and thoracic deformities in children can be treated with vertical expandable prosthetic titanium ribs (VEPTR©, Synthes GmbH®) to stimulate thoracic and spinal growth. With these implants children's symptoms and conditions can be slowed, halted or even reversed. Because of the dynamic character of the deformity and the growth of the children, the implants have to be lengthened about every half a year. With each operation there is a small risk of infection, which might increase with number of previous surgeries. Implant associated infections are often not clinical apparent and only found in microbiological analysis. To objectify the infection rate, identify potential precursors of infections and the relevance of asymptomatic infections in children with these implants a prospective study is conducted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with severe spinal or throacic deformities treates with VEPTR-implants. In these patients the implant has to be revised every half a year due to grow and achieved correction.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* all patients admitted at the University Children's Hospital Basel in whom a VEPTR©-implant or parts of it will be removed.\n\nExclusion Criteria:\n\n* obvious contamination of an explanted component occurred in the operating room."}, 'identificationModule': {'nctId': 'NCT01085669', 'briefTitle': 'Infection Rate of Vertical Expandable Prosthetic Titanium Rib Implants (VEPTR)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Infection Rate of VEPTR-Implants in Children With Severe Spinal and Thoracic Deformities', 'orgStudyIdInfo': {'id': 'EKBB 304/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VEPTR patients', 'description': 'Children treated with VEPTR Implants for severe spinal or thoracic deformities', 'interventionNames': ['Device: Microbiological analysis of retained VEPTR Implants']}], 'interventions': [{'name': 'Microbiological analysis of retained VEPTR Implants', 'type': 'DEVICE', 'description': 'Implants have to be adapted every half a year, the retained implants during revision are analysed for biological colonization.', 'armGroupLabels': ['VEPTR patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4005', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Daniel Studer, MD', 'role': 'CONTACT', 'email': 'Daniel.Studer@ukbb.ch', 'phone': '+41 685 6565'}, {'name': 'Carol Claudius Hasler, MD, PhD', 'role': 'CONTACT', 'email': 'Carolclaudius.hasler@ukbb.ch', 'phone': '+41 685 5350'}, {'name': 'Daniel Studer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orthopaedic Department, University Children´s Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Christian Plaass, MD', 'role': 'CONTACT', 'email': 'Christian@Plaass.info', 'phone': '+49 152 29098211'}, {'name': 'Carol Claudius Hasler, MD, PhD', 'role': 'CONTACT', 'email': 'Carolclaudius.hasler@ukbb.ch', 'phone': '+41 685 5350'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'collaborators': [{'name': "University Children's Hospital Basel", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'PD Dr. Carol-C. Hasler, Head Spine Surgery', 'oldOrganization': 'Orthopaedic Department, University Children´s Hospital Basel'}}}}