Surgical Treatment of Cervical Spondylotic Myelopathy

Completed

• Conditions: Cervical Spondylotic Myelopathy

• Registration Number: NCT00565734
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-29
• Study First Posted: 2007-11-30
• Primary Completion: 2014-09
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 479

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical complications and neurological, functional, disease-specific and quality of life measures	24 months

Secondary Outcome Measures

Name	Time	Method
Differences in patient presentation, treatment approaches and treatment outcomes among ethnic/racial groups, health care systems and regions of the world	24 months

Trial Locations

Locations (1)

Univerity of Toronto; 🇨🇦 Toronto, Ontario, Canada