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Surgical Treatment of Cervical Spondylotic Myelopathy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AOSpine International
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00565734
First received: November 29, 2007
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: November 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Posterior surgical approaches
Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM)
Anterior surgical approaches
Anterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565734

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

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00565734     History of Changes
Other Study ID Numbers: CSM-I 07
Study First Received: November 29, 2007
Last Updated: March 6, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013