Ignite Creation Date:
2025-12-24 @ 4:06 PM
Ignite Modification Date:
2026-02-24 @ 12:25 AM
Study NCT ID:
NCT02187666
Status:
UNKNOWN
Last Update Posted:
2014-07-11
First Post:
2014-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NOC2 Spine Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013122', 'term': 'Spinal Diseases'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-09', 'studyFirstSubmitDate': '2014-07-09', 'studyFirstSubmitQcDate': '2014-07-09', 'lastUpdatePostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Visual Analogue Scale (VAS) from baseline at 4 weeks', 'timeFrame': 'baseline and 4 weeks after surgery', 'description': 'Pain intensity scale taken at baseline and 4 weeks after surgery'}, {'measure': 'Change in Visual Analogue Scale (VAS) from baseline at 3 months', 'timeFrame': 'baseline and 3 months after surgery', 'description': 'Pain intensity scale taken at baseline and 3 months after surgery'}, {'measure': 'Change in Visual Analogue Scale (VAS) from baseline at 6 months', 'timeFrame': 'baseline and 6 months after surgery', 'description': 'Pain intensity scale taken at baseline and 6 months after surgery'}, {'measure': 'Change in Visual Analogue Scale (VAS) from baseline at 12 months', 'timeFrame': 'baseline and 12 months after surgery', 'description': 'Pain intensity scale taken at baseline and 12 months after surgery'}, {'measure': 'Change in Visual Analogue Scale (VAS) from baseline at 24 months', 'timeFrame': 'baseline and 24 months after surgery', 'description': 'Pain intensity scale taken at baseline and 24 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Oswestry Disability index at 4 weeks', 'timeFrame': 'baseline and 4 weeks after surgery', 'description': 'Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 4 weeks after surgery.'}, {'measure': 'Fusion at 6 months', 'timeFrame': '6 months post-op'}, {'measure': 'Length of hospital stay', 'timeFrame': 'one to three days following surgery', 'description': 'Date of discharge will be recorded, an average of one to three days'}, {'measure': 'Revision surgery within 30 days', 'timeFrame': '30 days after surgery'}, {'measure': 'Return to work', 'timeFrame': '4 weeks after surgery', 'description': 'Time off of work and whether patient returned restricted or unrestricted'}, {'measure': 'Return to normal/usual activity', 'timeFrame': '4 weeks after surgery', 'description': 'Time between surgery and resuming normal activity for patient'}, {'measure': 'Complications', 'timeFrame': '24 hours after surgery'}, {'measure': 'Change from baseline in Oswestry Disability index at 3 months', 'timeFrame': 'baseline and 3 months after surgery', 'description': 'Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 3 months after surgery.'}, {'measure': 'Change from baseline in Oswestry Disability index at 6 months', 'timeFrame': 'baseline and 6 months after surgery', 'description': 'Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 6 months after surgery.'}, {'measure': 'Change from baseline in Oswestry Disability index at 12 months', 'timeFrame': 'baseline and 12 months after surgery', 'description': 'Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 12 months after surgery.'}, {'measure': 'Change from baseline in Oswestry Disability index at 24 months', 'timeFrame': 'baseline and 24 months after surgery', 'description': 'Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 24 months after surgery.'}, {'measure': 'Return to work', 'timeFrame': '3 months after surgery', 'description': 'Time off of work and whether patient returned restricted or unrestricted'}, {'measure': 'Return to work', 'timeFrame': '6 months after surgery', 'description': 'Time off of work and whether patient returned restricted or unrestricted'}, {'measure': 'Return to work', 'timeFrame': '12 months after surgery', 'description': 'Time off of work and whether patient returned restricted or unrestricted'}, {'measure': 'Return to work', 'timeFrame': '24 months after surgery', 'description': 'Time off of work and whether patient returned restricted or unrestricted'}, {'measure': 'Return to normal/usual activity', 'timeFrame': '3 months after surgery', 'description': 'Time between surgery and resuming normal activity for patient'}, {'measure': 'Return to normal/usual activity', 'timeFrame': '6 months after surgery', 'description': 'Time between surgery and resuming normal activity for patient'}, {'measure': 'Return to normal/usual activity', 'timeFrame': '12 months after surgery', 'description': 'Time between surgery and resuming normal activity for patient'}, {'measure': 'Return to normal/usual activity', 'timeFrame': '24 months after surgery', 'description': 'Time between surgery and resuming normal activity for patient'}, {'measure': 'Complications', 'timeFrame': '4 weeks after surgery'}, {'measure': 'Complications', 'timeFrame': '3 months after surgery'}, {'measure': 'Complications', 'timeFrame': '6 months after surgery'}, {'measure': 'Complications', 'timeFrame': '12 months after surgery'}, {'measure': 'Complications', 'timeFrame': '24 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cervical', 'Lumbar', 'Spine', 'Spinal Disease'], 'conditions': ['Spinal Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.dc2healthcare.com', 'label': 'DC2 Healthcare'}, {'url': 'http://www.nriom.com/', 'label': 'NRIOM'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the Spine Registry is to enhance the understanding of spinal disease and treatment of spinal disease with the goal of guiding treatment options.', 'detailedDescription': 'This study will enhance the understanding of the variability, progression and treatment of spinal disease with the ultimate goal of better guiding and assessing therapeutic intervention. Researchers will collect complications and safety following cervical and lumbar surgeries to determine best options for patients. Prospective reports will be collected on patients undergoing lumbar or cervical spinal surgery. Patients will be enrolled in registry after signing informed consent. Data will be collected at various time points. The registry will serve as a database of cervical and lumbar surgeries in which retrospective analysis and exploratory analysis of specific research questions can be answered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Approximately 10,000 patients undergoing lumbar or cervical surgery will be screened to decide whether they meet the inclusion and exclusion criteria of the study/patient registry. Patients who meet the study criteria will be informed by the investigator and should read the 'patient information' document. Patients must give their written informed consent to be enrolled into this study.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing lumbar or cervical surgery\n* Understand and sign informed consent\n\nExclusion Criteria:\n\n* There are no specific exclusion criteria'}, 'identificationModule': {'nctId': 'NCT02187666', 'briefTitle': 'NOC2 Spine Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'DC2 Healthcare'}, 'officialTitle': 'National Neurosurgical and Orthopedic Optimum Care Continuum Spine Registry Exposure for Various Implants/Products', 'orgStudyIdInfo': {'id': 'NOC 1001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lumbar', 'description': 'Patients undergoing lumbar spinal surgery'}, {'label': 'Cervical', 'description': 'Patients undergoing cervical spine surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christina R Cook, PhD', 'role': 'CONTACT', 'email': 'ccook@dc2healthcare.com', 'phone': '615-712-9574'}, {'name': 'Risa Tyo, PharmD', 'role': 'CONTACT', 'email': 'rtyo@dc2healthcare.com', 'phone': '615-712-9574'}], 'facility': 'DC2 Healthcare', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Christina R Cook, PhD', 'role': 'CONTACT', 'email': 'ccook@dc2healthcare.com', 'phone': '615-712-9574'}, {'name': 'Risa Tyo, PharmD', 'role': 'CONTACT', 'email': 'rtyo@dc2healthcare.com', 'phone': '615-712-9574'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DC2 Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2)', 'class': 'UNKNOWN'}, {'name': 'National Research Independent Operations Management', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}