Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-26 @ 12:47 AM
Study NCT ID:
NCT01372592
Status:
COMPLETED
Last Update Posted:
2025-12-24
First Post:
2011-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SpineTRACK Registry - Spinal Outcomes Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8079}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2011-03-25', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To create a database of radiographic and clinical outcome measures of spinal surgery patients to evaluate the efficacy of various procedures for multiple diagnoses.', 'timeFrame': '24 months then annually thereafter'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vertebra; Degeneration', 'Spinal Trauma', 'Spinal Deformity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nuvasive.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The Spine TRACK Spinal Surgery Registry is a prospective multi-center observational data collection initiative, to capture clinical and radiographic outcomes in candidates for spine surgery with degenerative, deformity, and traumatic pathologies. As an observational database, there are no initial driving hypotheses, but rather data will be mined to answer unforeseen questions, but which may include broad topics such as comparative effectiveness between and among various surgical treatment options, and/or outcomes in various subgroups of patients such as defined by demographics, comorbidities, indications and symptoms, treatment variables, and/or outcome variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who are evaluated and scheduled to undergo surgical treatment for a spine-related condition are eligible to participate in this registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Candidate for spinal surgery'}, 'identificationModule': {'nctId': 'NCT01372592', 'briefTitle': 'SpineTRACK Registry - Spinal Outcomes Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Globus Medical Inc'}, 'officialTitle': 'SpineTRACK (Translating Radiographic and Clinical Knowledge) Registry: Outcomes Data Collection in Degenerative, Deformity, and Trauma Patients', 'orgStudyIdInfo': {'id': 'NUVA.REG1101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Degenerative', 'description': 'Patients being treated for degenerative spine conditions.', 'interventionNames': ['Procedure: Surgery']}, {'label': 'Deformity', 'description': 'Patients being treated for a deformity spine condition.', 'interventionNames': ['Procedure: Surgery']}, {'label': 'Trauma', 'description': 'Patients being treated for a trauma related spine condition.', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Patients will receive standard of care surgical treatment dependent on his/her spinal condition.', 'armGroupLabels': ['Deformity', 'Degenerative', 'Trauma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85251', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Spine Group Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'SD Center for Spinal Disorders', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Orthopaedic Specialty Institute', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Dept. of Orthopaedic Surgery', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '81301', 'city': 'Durango', 'state': 'Colorado', 'country': 'United States', 'facility': 'Durango Orthopaedics', 'geoPoint': {'lat': 37.27528, 'lon': -107.88007}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida Department of Neurosurgery, Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Physicians', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Orthopaedics at Rush University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46278', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'OrthoIndy Northwest', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65101', 'city': 'Jefferson City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Spine Midwest', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Spinemore, LLC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08755', 'city': 'Tomas River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Ocean Orthopaedics'}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27288', 'city': 'Eden', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Morehead NeuroSpine', 'geoPoint': {'lat': 36.48847, 'lon': -79.7667}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Bone & Joint Surgery Clinic', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Orthopaedics', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'NeuroSpine Institute', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Team2 Solutions, LLC', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Orthopedics & Sports Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78738', 'city': 'Lakeway', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Spine', 'geoPoint': {'lat': 30.36377, 'lon': -97.97959}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Salt Lake Orthopedic Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98372', 'city': 'Puyallup', 'state': 'Washington', 'country': 'United States', 'facility': 'NeoSpine', 'geoPoint': {'lat': 47.18538, 'lon': -122.2929}}, {'zip': '99208', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Orthopaedic Specialists, PS', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'São Paulo', 'state': 'BR', 'country': 'Brazil', 'facility': 'Luis Pimenta, MD', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital Ortopedico', 'geoPoint': {'lat': -8.96667, 'lon': -72.78333}}], 'overallOfficials': [{'name': 'Kyle Malone, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NuVasive'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NuVasive', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}