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Surgical Treatment of Cervical Spondylotic Myelopathy

Sponsor
AO Clinical Investigation and Publishing Documentation (Other)
Overall Status
Completed
CT.gov ID
NCT00565734
Collaborator
AO Foundation, AO Spine (Other)
479
Enrollment
1
Location
86
Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    479 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
    Study Start Date :
    Nov 1, 2007
    Actual Primary Completion Date :
    Sep 1, 2014
    Actual Study Completion Date :
    Jan 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Posterior surgical approaches

    Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM)
    Anterior surgical approaches

    Anterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM).

    Outcome Measures

    Primary Outcome Measures

    1. Surgical complications and neurological, functional, disease-specific and quality of life measures [24 months]

    Secondary Outcome Measures

    1. Differences in patient presentation, treatment approaches and treatment outcomes among ethnic/racial groups, health care systems and regions of the world [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age > 18 years

    • 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:

    • Asymptomatic CSM

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Univerity of Toronto Toronto Ontario Canada M5T 2S8

    Sponsors and Collaborators

    • AO Clinical Investigation and Publishing Documentation
    • AO Foundation, AO Spine

    Investigators

    • Principal Investigator: Michael Fehlings, MD, PhD, University of Troronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AO Clinical Investigation and Publishing Documentation
    ClinicalTrials.gov Identifier:
    NCT00565734
    Other Study ID Numbers:
    • CSM-I 07
    First Posted:
    Nov 30, 2007
    Last Update Posted:
    Mar 6, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Spinal Cord Diseases
    Bone Marrow Diseases

    Study Results

    No Results Posted as of Mar 6, 2015