Surgical Treatment of Cervical Spondylotic Myelopathy

An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00565734

Enrollment

479

Registered

2007-11-30

Start date

2007-11-30

Completion date

2015-01-31

Last updated

2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spondylotic Myelopathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results