Surgical Treatment of Cervical Spondylotic Myelopathy

March 5, 2015 updated by: AO Clinical Investigation and Publishing Documentation

An Assessment of Surgical Techniques for Treating 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

479

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Univerity of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical complications and neurological, functional, disease-specific and quality of life measures
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Collaborators

AO Foundation, AO Spine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 29, 2007

First Submitted That Met QC Criteria

November 29, 2007

First Posted (Estimate)

November 30, 2007

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSM-I 07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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