Surgical Treatment of Cervical Spondylotic Myelopathy

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Cervical Spondylotic Myelopathy

Study type: Observational

Funder types: Other

Identifiers

NCT00565734

CSM-I 07

Details and patient eligibility

About

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.

Enrollment: 479 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

479 participants in 2 patient groups

Posterior surgical approaches

Description:

Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM)

Anterior surgical approaches

Description:

Anterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM).