Cervical Spondylotic MyelopathyNCT00565734
Surgical Treatment of Cervical Spondylotic Myelopathy
An observational study of Cervical Spondylotic Myelopathy, run by AO Clinical Investigation and Publishing Documentation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spondylotic Myelopathy
- How many people
- 479 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 20Show fewer
- 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
Who cannot join
- Asymptomatic CSM
- Previous surgery for CSM
- Active infection
- Neoplastic disease
- Rheumatoid arthritis
- Ankylosing spondylitis
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cervical Spondylotic Myelopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Posterior surgical approaches | Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM) | |
| Anterior surgical approaches | Anterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complications and neurological, functional, disease-specific and quality of life measures
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical Spondylotic MyelopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Responsible party
- Sponsor
- Investigators
- Michael Fehlings, MD, PhD, Principal investigator, University of Troronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565734
- Sponsor's protocol ID
- CSM-I 07
- Status last verified
- Mar 2015
- First submitted
- 29 Nov 2007
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pedro KM, Alvi MA, Lozano C, Karthikeyan V, Wilson JR, Badhiwala JH, Anderson DB, Davies BM, Barbagallo GMV, Harrop JS, Fehlings MG. Neck Pain Is a Key Determinant of Health-Related Quality-of-Life Outcome in Degenerative Cervical Myelopathy. Neurosurgery. 2026 Mar 20. doi: 10.1227/neu.0000000000003999. Online ahead of print.
PubMed 41860228Bak 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. 2026 Mar 1;167(3):654-662. doi: 10.1097/j.pain.0000000000003828. Epub 2025 Oct 15.
PubMed 41086299Wong 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. 2026 Jan;16(1):218-229. doi: 10.1177/21925682251341263. Epub 2025 May 10.
PubMed 40347099Pedro 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 Jun 1;94(6):1122-1131. doi: 10.1227/neu.0000000000002818. Epub 2024 Jan 10.
PubMed 38197642Merali 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.
PubMed 30947300
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
- ClinicalTrials.gov ID
- NCT00565734
- Acronym / sponsor ID
- CSM-I 07
- Conditions
- Cervical Spondylotic Myelopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- AO Foundation, AO Spine
- Study start
- Nov 2007
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior surgical approaches | – | –Posterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM) |
| Anterior surgical approaches | – | –Anterior surgical approaches for symptomatic cervical spondylotic myelopathy (CSM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (14 listed)
- Asymptomatic CSM
- Previous surgery for CSM
- Active infection
- Neoplastic disease
- Rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical complications and neurological, functional, disease-specific and quality of life measures
Time frame: 24 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Derived from this study: PubMed 41860228Pedro KM, Alvi MA, Lozano C, Karthikeyan V, Wilson JR, Badhiwala JH, Anderson DB, Davies BM, Barbagallo GMV, Harrop JS, Fehlings MG. Neck Pain Is a Key Determinant of Health-Related Quality-of-Life Outcome in Degenerative Cervical Myelopathy. Neurosurgery. 2026 Mar 20. doi: 10.1227/neu.0000000000003999. Online ahead of print.
- Derived from this study: PubMed 41086299Bak 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. 2026 Mar 1;167(3):654-662. doi: 10.1097/j.pain.0000000000003828. Epub 2025 Oct 15.
- Derived from this study: PubMed 40347099Wong 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. 2026 Jan;16(1):218-229. doi: 10.1177/21925682251341263. Epub 2025 May 10.
- Derived from this study: PubMed 38197642Pedro 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 Jun 1;94(6):1122-1131. doi: 10.1227/neu.0000000000002818. Epub 2024 Jan 10.
- Derived from this study: PubMed 30947300Merali 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fehlings, MD, PhD principal investigator
University of Troronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylotic Myelopathy, run by AO Clinical Investigation and Publishing Documentation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical complications and neurological, functional, disease-specific and quality of life measures (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00565734, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.