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OpenTrials
Completed

NCT Number: NCT00565734

Surgical Treatment of Cervical Spondylotic Myelopathy

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.

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Key information

Conditions

Cervical Spondylotic Myelopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Univerity of Toronto

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Surgical complications and neurological, functional, disease-specific and quality of life measures

    Time frame: 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Collaborators

  • AO Foundation, AO Spine

Registry information

Official study title

An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy

Important dates

Study start
2007
Primary completion
2014
Study completion
2015
First posted
Nov 30, 2007
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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