Surgical Treatment of Cervical Spondylotic Myelopathy - Full Text View

Surgical Treatment of Cervical Spondylotic Myelopathy

This study is currently recruiting participants.
Verified by AO Clinical Investigation and Documentation, May 2008

Sponsors and Collaborators:	AO Clinical Investigation and Documentation AOSpine International
Information provided by:	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT00565734

Purpose

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.

Condition	Intervention	Phase
Cervical Spondylotic Myelopathy	Procedure: standard surgical care for CSM treatment	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title:	An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:

Surgical complications and neurological, functional, disease-specific and quality of life measures [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	375
Study Start Date:	November 2007
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Surgical intervention in order to alleviate the CSM status

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565734

Contacts


Contact: Peter Langer, PhD	41-44-200-2468	peter.langer@aofoundation.org

Locations


Canada, Ontario
	Univerity of Toronto	Recruiting
	Toronto, Ontario, Canada, M5T 2S8
	Contact: Michael Fehlings, MD, PhD 416-603-5627 michael.fehlings@uhn.on.ca

Sponsors and Collaborators

AO Clinical Investigation and Documentation

AOSpine International

Investigators


Principal Investigator:	Michael Fehlings, MD, PhD	University of Troronto

More Information

Responsible Party:	AO Clinical Investigation and Documentation ( Peter Langer )
Study ID Numbers:	CSM-I 07
First Received:	November 29, 2007
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00565734
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Spinal Cord Diseases

Central Nervous System Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008