An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy

AO Clinical Investigation and Publishing Documentation1 site in 1 country479 target enrollmentNovember 2007

ConditionsCervical Spondylotic Myelopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cervical Spondylotic Myelopathy
Sponsor: AO Clinical Investigation and Publishing Documentation
Enrollment: 479
Locations: 1
Primary Endpoint: Surgical complications and neurological, functional, disease-specific and quality of life measures
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

January 2015

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AO Clinical Investigation and Publishing Documentation

Responsible Party

Sponsor

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

Exclusion Criteria

•Asymptomatic CSM
•Previous surgery for CSM
•Active infection
•Neoplastic disease
•Rheumatoid arthritis
•Ankylosing spondylitis
•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

Outcomes

Primary Outcomes

Surgical complications and neurological, functional, disease-specific and quality of life measures

Time Frame: 24 months

Secondary Outcomes

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