Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT01017692
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2009-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging (MRI) Interpretations for Lumbar Spinal Stenosis (LSS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-22', 'studyFirstSubmitDate': '2009-11-18', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "A numeric score will be calculated for the actual percent stenosis at the symptomatic level(s) and will report the predictive power of MRI based on all the analysis of MRI with and without clinical knowledge of patient's presenting symptoms", 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lumbar Spinal Stenosis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to establish a relationship between the degree of radiologically established anatomical stenosis and the severity of self-assessed outcome measures in patients that have undergone and MRI.', 'detailedDescription': 'Magnetic Resonance Imaging(MRI) has become the gold standard of evaluation of lumbar spinal stenosis (LSS. LSS is defined as the narrowing of the spinal canal. Thus far, there has been no formal grading system in literature. Physicians, particularly radiologists, in their interpretations, currently describe the degree of stenosis at each level as normal, mild, moderate or severe. Unfortunately, there is no consensus on criteria of these definitions. Treatments and surgical plans are based primarily on this information. Consequently, the reliability and accuracy of this information is critical in terms of optimizing outcomes.\n\nIn this study 50-100 MRI studies of patients diagnosed with symptomatic lumbar spinal stenosis will be collected, de-identified, and assigned a study identification number for tracking purposes. Three "raters" from Upstate and three "rater" from outside the institution, that have experience reviewing MRI\'s will be asked to review the MRI\'s and classify the LSS at all lumbar levels as normal, mild, moderate or severe in the central canal, lateral recesses and the neuroforamen. The raters will not have any information about the patients. The MRI\'s will then be given a new identification number, and the patient\'s self-assessment questionnaires (which are also de-identified and given the study id number) will be given to the raters, for a second review. The raters will have the patients gender, age and outcomes scores from Short form 36, Visual Analog Scale, Oswestry Disability Index and Zurich Claudication Questionnaires. The raters will classify the MRI, as normal, mild, moderate or severe using the outcomes and information supplied.\n\nThe data from both ratings will be compiled and compared to assess the reliability of the radiologically established anatomical stenosis when compared with the subjects outcome scores.\n\nThis study is for current patients in Upstate Orthopedics office.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are seen at SUNY Upstate Medical Univeristy, Department of Orthopedic Surgery office', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be at least 21 years of age\n* Must be able to undergo or have undergone an MRI of the Lumbar spine\n* Must be able to read/understand English\n* Must be a current patient in our practice\n\nExclusion Criteria:\n\n* Prisoner'}, 'identificationModule': {'nctId': 'NCT01017692', 'briefTitle': 'Magnetic Resonance Imaging (MRI) Interpretations for Lumbar Spinal Stenosis (LSS)', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Upstate Medical University'}, 'officialTitle': 'Variability of Magnetic Resonancy Imaging Interpretation for Lumbar Spinal Stenosis', 'orgStudyIdInfo': {'id': '5825-MRI Variability'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lumbar Spinal Stenosis', 'description': 'Subjects who have undergone or will undergo an MRI, with symptoms of LSS', 'interventionNames': ['Procedure: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'PROCEDURE', 'description': 'MRI of lumbar spine for subjects presenting with spinal stenosis symptoms', 'armGroupLabels': ['Lumbar Spinal Stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13202', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University-Department of Orthopedics', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}], 'overallOfficials': [{'name': 'William F Lavelle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York - Upstate Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Upstate Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'William Lavelle', 'investigatorAffiliation': 'State University of New York - Upstate Medical University'}}}}