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Surgical Treatment of Cervical Spondylotic Myelopathy

This study has been completed.
AOSpine International
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation Identifier:
First received: November 29, 2007
Last updated: March 5, 2015
Last verified: March 2015
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 Phase
Cervical Spondylotic Myelopathy
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy

Resource links provided by NLM:

Further study details as provided by AO Clinical Investigation and Documentation:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 479
Study Start Date: November 2007
Study Completion Date: January 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Posterior surgical approaches
Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM)
Anterior surgical approaches
Anterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00565734

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

Responsible Party: AO Clinical Investigation and Documentation Identifier: NCT00565734     History of Changes
Other Study ID Numbers: CSM-I 07
Study First Received: November 29, 2007
Last Updated: March 5, 2015

Additional relevant MeSH terms:
Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases processed this record on April 28, 2017