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Trial record 20 of 22 for:    aospine

Surgical Treatment of Cervical Spondylotic Myelopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565734
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : March 6, 2015
AOSpine International
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

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
Cervical Spondylotic Myelopathy

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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 : November 2007
Actual Primary Completion Date : September 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Surgical complications and neurological, functional, disease-specific and quality of life measures [ Time Frame: 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 [ Time Frame: 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00565734

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Canada, Ontario
Univerity of Toronto
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOSpine International
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Principal Investigator: Michael Fehlings, MD, PhD University of Troronto

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AO Clinical Investigation and Documentation Identifier: NCT00565734    
Other Study ID Numbers: CSM-I 07
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases