ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Surgical Treatment of Cervical Spondylotic Myelopathy

This study is currently recruiting participants.
Verified by AO Clinical Investigation and Documentation, May 2008

Sponsors and Collaborators: AO Clinical Investigation and Documentation
AOSpine International
Information provided by: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00565734
  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 Intervention Phase
Cervical Spondylotic Myelopathy
Procedure: standard surgical care for CSM treatment
Phase IV

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:   An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy

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:   April 2011
Estimated Primary Completion Date:   April 2011 (Final data collection date for primary outcome measure)

Intervention Details:
    Procedure: standard surgical care for CSM treatment
    Surgical intervention in order to alleviate the CSM status
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

Contacts
Contact: Peter Langer, PhD     41-44-200-2468     peter.langer@aofoundation.org    

Locations
Canada, Ontario
Univerity of Toronto     Recruiting
      Toronto, Ontario, Canada, M5T 2S8
      Contact: Michael Fehlings, MD, PhD     416-603-5627     michael.fehlings@uhn.on.ca    

Sponsors and Collaborators
AO Clinical Investigation and Documentation
AOSpine International

Investigators
Principal Investigator:     Michael Fehlings, MD, PhD     University of Troronto    
  More Information


Responsible Party:   AO Clinical Investigation and Documentation ( Peter Langer )
Study ID Numbers:   CSM-I 07
First Received:   November 29, 2007
Last Updated:   May 6, 2008
ClinicalTrials.gov Identifier:   NCT00565734
Health Authority:   Canada: Ethics Review Committee

Study placed in the following topic categories:
Spinal Cord Diseases
Central Nervous System Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers