NCT00565734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
479

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

6.8 years

First QC Date

November 29, 2007

Last Update Submit

March 5, 2015

Conditions

Cervical Spondylotic Myelopathy

Outcome Measures

Primary Outcomes (1)

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

    24 months

Secondary Outcomes (1)

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

    24 months

Study Arms (2)

Posterior surgical approaches

Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM)

Anterior surgical approaches

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic CSM who referred for surgical consultation to the corresponding participating site's orthopedic or neurosurgery services will be eligible for this study.

You may qualify if:

  • 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
  • +5 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerity of Toronto

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (4)

  • 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.

    PMID: 41086299DERIVED

  • 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;16(1):21925682251341263. doi: 10.1177/21925682251341263. Online ahead of print.

    PMID: 40347099DERIVED

  • 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.

    PMID: 38197642DERIVED

  • 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.

    PMID: 30947300DERIVED

Study Officials

  • Michael Fehlings, MD, PhD

    University of Troronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2007

First Posted

November 30, 2007

Study Start

November 1, 2007

Primary Completion

September 1, 2014

Study Completion

January 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

CA(1)