Surgical Treatment of Cervical Spondylotic Myelopathy

Cervical Spondylotic Myelopathy Clinical Trial

Official title:

An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565734
• Other study ID #: CSM-I 07
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2007
• Last updated: March 5, 2015
• Start date: November 2007
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Spondylotic Myelopathy

Locations

Country	Name	City	State
Canada	Univerity of Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation	AOSpine International

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical complications and neurological, functional, disease-specific and quality of life measures		24 months	No
Secondary	Differences in patient presentation, treatment approaches and treatment outcomes among ethnic/racial groups, health care systems and regions of the world		24 months	No