Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
479 participants
OBSERVATIONAL
2007-11-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Posterior surgical approaches
Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM)
No interventions assigned to this group
Anterior surgical approaches
Anterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Willing and able to give written informed consent to participate in the study
* Willing and able to participate in the study follow-up according to the protocol
* Willing and able to comply with post-operative management program
* Understand and read country language at elementary level
* Patients who undergo surgery for symptomatic CSM defined as a combination of one or more of the following symptoms:
* Numb hands
* Clumsy hands
* Impairment of gait
* Bilateral arm paresthesiae
* l'Hermitte's phenomena
* Weakness
AND one or more of the following signs:
* Corticospinal distribution motor deficits
* Atrophy of hand intrinsic muscles
* Hyperreflexia
* Positive Hoffman sign
* Upgoing plantar responses
* Lower limb spasticity
* Broad based, unstable gait
Exclusion Criteria
* Previous surgery for CSM
* Active infection
* Neoplastic disease
* Rheumatoid arthritis
* Ankylosing spondylitis
* Trauma
* Concomitant symptomatic lumbar stenosis
* Pregnant women or women planning to get pregnant during the study period
* Has a history of substance abuse (recreational drugs, alcohol)
* Is a prisoner
* Is currently involved in a study with similar purpose
* Has a disease process that would preclude accurate evaluation (eg., neuromuscular disease, significant psychiatric disease)
* Patients seen by other services (eg., physical medicine, neurology, family practice), managed conservatively and not referred for surgical consultation are ineligible.
18 Years
ALL
No
Sponsors
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AO Foundation, AO Spine
OTHER
AO Clinical Investigation and Publishing Documentation
OTHER
Responsible Party
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Principal Investigators
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Michael Fehlings, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Troronto
Locations
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Univerity of Toronto
Toronto, Ontario, Canada
Countries
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References
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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.
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 10:21925682251341263. doi: 10.1177/21925682251341263. Online ahead of print.
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.
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.
Other Identifiers
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CSM-I 07
Identifier Type: -
Identifier Source: org_study_id
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