Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-07 @ 7:32 PM
Study NCT ID:
NCT01666860
Status:
COMPLETED
Last Update Posted:
2012-08-17
First Post:
2012-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-16', 'studyFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A clinical evaluation before an Anterior Lumbar Interbody Fusion procedure.', 'timeFrame': 'Baseline', 'description': 'The clinical result will be stipulated by means of standardized questionnaires.'}, {'measure': 'A clinical evaluation after an Anterior Lumbar Interbody Fusion procedure.', 'timeFrame': '5 years after the operation', 'description': 'The clinical result will be stipulated by means of standardized questionnaires.'}], 'secondaryOutcomes': [{'measure': 'Union of the vertebrae.', 'timeFrame': '1 day (At the standard follow up consultation)', 'description': 'Standard post operative X-ray.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anterior lumbar interbody fusion'], 'conditions': ['Anterior Lumbar Interbody Fusion Procedure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'During the period 1989-1999, a number of patients underwent an ALIF-procedure. Anterior Lumbar Interbody Fusion procedure (ALIF) is a type of lumbar spinal fusion. The approach of the lumbar region is by incision of the abdominal wall. The intervertebral disc is removed and replaced by a bone graft. These patients form the population of this study. The goal of this study is to evaluate their current medical condition and to determine the clinical outcome.\n\nThe clinical result will be stipulated by means of standardized questionnaires (VAS-score, Oswestry low Back Pain Questionnaire and SF-36)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have an Anterior Lumbar Interbody Fusion Procedure as treatment for degenerative disc disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An Anterior Lumbar Interbody Fusion procedure between 1999 and 2005\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01666860', 'briefTitle': 'Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Long-term Follow-up of the Anterior Lumbar Interbody Fusion Procedure.', 'orgStudyIdInfo': {'id': '2010/740'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anterior Lumbar Interbody Fusion procedure', 'interventionNames': ['Procedure: Anterior Lumbar Interbody Fusion procedure']}], 'interventions': [{'name': 'Anterior Lumbar Interbody Fusion procedure', 'type': 'PROCEDURE', 'armGroupLabels': ['Anterior Lumbar Interbody Fusion procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Bart Poffyn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}