Surgical Treatment of Cervical Spondylotic Myelopathy

NCT ID: NCT00565734

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

479 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Spondylotic Myelopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Posterior surgical approaches

Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM)

No interventions assigned to this group

Anterior surgical approaches

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AO Foundation, AO Spine

OTHER

Sponsor Role collaborator

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Fehlings, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Troronto

Locations

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Univerity of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Bak AB, Moghaddamjou A, Arnold PM, Harrop JS, Fehlings MG. Chronic pain after decompression for degenerative cervical myelopathy: a pooled trajectory analysis of individual participant data. Pain. 2025 Oct 15. doi: 10.1097/j.pain.0000000000003828. Online ahead of print.

Reference Type DERIVED
PMID: 41086299 (View on PubMed)

Wong R, Alvi MA, Quddusi AI, Fehlings MG. Role of Neck Pain in Defining Clinical Trajectories of Outcomes in Patients With Degenerative Cervical Myelopathy: Results of a Novel Machine Learning Algorithm. Global Spine J. 2025 May 10:21925682251341263. doi: 10.1177/21925682251341263. Online ahead of print.

Reference Type DERIVED
PMID: 40347099 (View on PubMed)

Pedro KM, Alvi MA, Hejrati N, Moghaddamjou A, Fehlings MG. Elderly Patients Show Substantial Improvement in Health-Related Quality of Life After Surgery for Degenerative Cervical Myelopathy Despite Medical Frailty: An Ambispective Analysis of a Multicenter, International Data Set. Neurosurgery. 2024 Jan 10. doi: 10.1227/neu.0000000000002818. Online ahead of print.

Reference Type DERIVED
PMID: 38197642 (View on PubMed)

Merali ZG, Witiw CD, Badhiwala JH, Wilson JR, Fehlings MG. Using a machine learning approach to predict outcome after surgery for degenerative cervical myelopathy. PLoS One. 2019 Apr 4;14(4):e0215133. doi: 10.1371/journal.pone.0215133. eCollection 2019.

Reference Type DERIVED
PMID: 30947300 (View on PubMed)

Other Identifiers

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CSM-I 07

Identifier Type: -

Identifier Source: org_study_id

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