Clinical trial NCT00565734: Surgical Treatment of Cervical Spondylotic Myelopathy
Official title: An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Spondylotic Myelopathy
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: AO Foundation, AO Spine
First posted: 2007-11-30
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Surgical complications and neurological, functional, disease-specific and quality of life measures
timeFrame: 24 months
Secondary outcomes:
measure: Differences in patient presentation, treatment approaches and treatment outcomes among ethnic/racial groups, health care systems and regions of the world
timeFrame: 24 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Univerity of Toronto
state: Ontario
Study officials:
affiliation: University of Troronto
name: Michael Fehlings, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merali ZG, Witiw CD, Badhiwala JH, Wilson JR, Fehlings MG. Using a machine learning approach to predict outcome after surgery for degenerative cervical myelopathy. PLoS One. 2019 Apr 4;14(4):e0215133. doi: 10.1371/journal.pone.0215133. eCollection 2019.