Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT00565734
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2007-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment of Cervical Spondylotic Myelopathy
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': 479}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2007-11-29', 'studyFirstSubmitQcDate': '2007-11-29', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical complications and neurological, functional, disease-specific and quality of life measures', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Differences in patient presentation, treatment approaches and treatment outcomes among ethnic/racial groups, health care systems and regions of the world', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cervical Spondylotic Myelopathy']}, 'referencesModule': {'references': [{'pmid': '41086299', 'type': 'DERIVED', 'citation': 'Bak AB, Moghaddamjou A, Arnold PM, Harrop JS, Fehlings MG. Chronic pain after decompression for degenerative cervical myelopathy: a pooled trajectory analysis of individual participant data. Pain. 2025 Oct 15. doi: 10.1097/j.pain.0000000000003828. Online ahead of print.'}, {'pmid': '40347099', 'type': 'DERIVED', 'citation': 'Wong R, Alvi MA, Quddusi AI, Fehlings MG. Role of Neck Pain in Defining Clinical Trajectories of Outcomes in Patients With Degenerative Cervical Myelopathy: Results of a Novel Machine Learning Algorithm. Global Spine J. 2025 May 10;16(1):21925682251341263. doi: 10.1177/21925682251341263. Online ahead of print.'}, {'pmid': '38197642', 'type': 'DERIVED', 'citation': 'Pedro KM, Alvi MA, Hejrati N, Moghaddamjou A, Fehlings MG. Elderly Patients Show Substantial Improvement in Health-Related Quality of Life After Surgery for Degenerative Cervical Myelopathy Despite Medical Frailty: An Ambispective Analysis of a Multicenter, International Data Set. Neurosurgery. 2024 Jan 10. doi: 10.1227/neu.0000000000002818. Online ahead of print.'}, {'pmid': '30947300', 'type': 'DERIVED', 'citation': 'Merali ZG, Witiw CD, Badhiwala JH, Wilson JR, Fehlings MG. Using a machine learning approach to predict outcome after surgery for degenerative cervical myelopathy. PLoS One. 2019 Apr 4;14(4):e0215133. doi: 10.1371/journal.pone.0215133. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The primary purposes of this study are to compare anterior and posterior surgical approach in treatment of CSM ad to compare variations in treatment and outcomes of CSM worldwide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with symptomatic CSM who referred for surgical consultation to the corresponding participating site's orthopedic or neurosurgery services will be eligible for this study.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years\n* Willing and able to give written informed consent to participate in the study\n* Willing and able to participate in the study follow-up according to the protocol\n* Willing and able to comply with post-operative management program\n* Understand and read country language at elementary level\n* Patients who undergo surgery for symptomatic CSM defined as a combination of one or more of the following symptoms:\n* Numb hands\n* Clumsy hands\n* Impairment of gait\n* Bilateral arm paresthesiae\n* l'Hermitte's phenomena\n* Weakness\n\nAND one or more of the following signs:\n\n* Corticospinal distribution motor deficits\n* Atrophy of hand intrinsic muscles\n* Hyperreflexia\n* Positive Hoffman sign\n* Upgoing plantar responses\n* Lower limb spasticity\n* Broad based, unstable gait\n\nExclusion Criteria:\n\n* Asymptomatic CSM\n* Previous surgery for CSM\n* Active infection\n* Neoplastic disease\n* Rheumatoid arthritis\n* Ankylosing spondylitis\n* Trauma\n* Concomitant symptomatic lumbar stenosis\n* Pregnant women or women planning to get pregnant during the study period\n* Has a history of substance abuse (recreational drugs, alcohol)\n* Is a prisoner\n* Is currently involved in a study with similar purpose\n* Has a disease process that would preclude accurate evaluation (eg., neuromuscular disease, significant psychiatric disease)\n* Patients seen by other services (eg., physical medicine, neurology, family practice), managed conservatively and not referred for surgical consultation are ineligible."}, 'identificationModule': {'nctId': 'NCT00565734', 'briefTitle': 'Surgical Treatment of Cervical Spondylotic Myelopathy', 'organization': {'class': 'OTHER', 'fullName': 'AO Innovation Translation Center'}, 'officialTitle': 'An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy', 'orgStudyIdInfo': {'id': 'CSM-I 07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Posterior surgical approaches', 'description': 'Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM)'}, {'label': 'Anterior surgical approaches', 'description': 'Anterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM).'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Univerity of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Michael Fehlings, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Troronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AO Clinical Investigation and Publishing Documentation', 'class': 'OTHER'}, 'collaborators': [{'name': 'AO Foundation, AO Spine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}