| November 29, 2007 |
| August 5, 2009 |
| November 2007 |
| April 2011 (final data collection date for primary outcome measure) |
| Surgical complications and neurological, functional, disease-specific and quality of life measures [ Time Frame: 24 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00565734 on ClinicalTrials.gov Archive Site |
| Differences in patient presentation, treatment approaches and treatment outcomes among ethnic/racial groups, health care systems and regions of the world [ Time Frame: 24 months ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Surgical Treatment of Cervical Spondylotic Myelopathy |
| An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Cervical Spondylotic Myelopathy |
| Procedure: standard surgical care for CSM treatment |
| |
| |
| |
| Recruiting |
| 375 |
| April 2011 |
| April 2011 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years and older |
| No |
|
|
| Canada |
| |
| NCT00565734 |
| Peter Langer, AO Clinical Investigation and Documentation |
| CSM-I 07 |
| AO Clinical Investigation and Documentation |
| AOSpine International |
| Principal Investigator: |
Michael Fehlings, MD, PhD |
University of Troronto |
|
|
| AO Clinical Investigation and Documentation |
| August 2009 |
