Cervical Spondylotic MyelopathyCSMNCT00285337
Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
An observational study of Cervical Spondylotic Myelopathy, run by AOSpine North America Research Network at 13 sites in 2 countries.
Trial summary
The primary purpose of this study is to compare anterior and posterior surgical approach in treatment of CSM in terms of surgical complications and neurological, functional, disease-specific and quality of life outcomes measures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cervical Spondylotic Myelopathy
- What is being tested?
- Laminectomy and Laminoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 321 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Dec 2005to Nov 2007
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergo surgery for symptomatic cervical spondylotic myelopathy with one or or more of the following symptoms: Numb clumsy hands, impairment of gait, bilateral arm parasthesia, L'Hermitte's phenomena
- and one or more of the following signs: corticospinal distribution motor deficits, athropy of hand intrinsic muscles, hyperflexia, positive Hoffman sign, upgoing plantar responses, lower limb spasticity, broad based unstable gait
Who cannot join
- Asymptomatic cervical spondylotic myelopathy
- previous surgery for CSM
- Active infection
- Neoplastic disease
- Rheumatoid arthritis
- Ankylosing spondylitis
Show all 10Show fewer
- Trauma
- Concomitant lumbar stenosis
- Not referred for surgical consultation
- Participating in other trials or unlikely to attend follow-ups
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Emory University
Atlanta, Georgia, 30329
John Hopkins University
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
New England Baptist Hospital
Boston, Massachusetts, 02120
University Of Virginia
Charlottesville, Virginia, 22908
Indianda Spine Group
Indianapolis, Indiana, 46260
Kansas University Medical Center
Kansas City, Kansas, 66160
Thomas Jefferson University and Rothman Institure Orthopaedics
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
Universty of Utah
Salt Lake City, Utah, 84108
Harborview Medical Center
Seattle, Washington, 98104
Spine Education and Research Institute
Thornton, Colorado, 80229
About this study
Official title: An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
The primary purpose of this study is to compare anterior and posterior surgical approach in treatment of CSM in terms of surgical complications and neurological, functional, disease-specific and quality of life outcomes measures.
Secondary aims are to quantify the amount of change pre and post-surgery concerning the same outcome measures; to determine if there are differences in outcomes between posterior surgical techniques (i.e. laminectomy with fusion or laminoplasty) and examine the relationship between baseline MRI and baseline and follow-up neurological and functional outcomes.
Read the detailed description
Narrowing of the spinal canal by osteophytes, ossification of the posterior longitudinal ligament, or bulging of a large central disk can compress the cervical spinal cord and impinge the spinal nerve roots, resulting in neck pain and various degrees of neurological symptoms and impairment.2 In severe cases, this can lead to stenosis of the cervical spine, resulting in upper motor neuron symptoms in the lower extremity and lower motor neuron symptoms in the upper extremity. When conservative measures such as traction, cervical collar, and postural exercises fail to prevent neurologic progression, surgery may be indicated.
A variety of surgical approaches and procedures are available, and the optimal choice of treatment remains controversial. Surgical procedures designed to decompress the spinal cord and, in some cases, stabilize the spine have been shown to be successful, but there is a persistent percentage of patients who do not improve with surgical intervention.3 Additionally, the potential complications of surgery for CSM may depend on the various methods of surgical management. Historically, cervical laminectomy, a posterior approach, had been regarded as the standard surgical treatment of CSM. However, over the past 20 years, it has been increasingly recognized that laminectomy without fusion is not appropriate for all patients and may result in instability and deformity. Because of the instability caused by laminectomies, alternate surgical approaches such as anterior approaches to the spine and laminoplasty have been developed, and have gained increasing popularity over the years.3 A range of factors must be considered when deciding which surgical technique to use. Surgeons are often challenged with determining the most appropriate technique because there is limited information about whether there is a difference between surgical procedures in terms of clinical and radiographic outcomes, in postoperative complication rates and in functional and quality of life outcomes. Methods of treatment include conservative and surgical management. Among surgically managed patients, an anterior or posterior approach may be employed. Among those managed posteriorly, laminoplasty or laminectomy with fusion are common surgical techniques. With several standards of care available for this population, a better understanding of the corresponding positive and negative outcomes with respect to clinical and patient-centered outcomes is warranted.
- Conditions
- Cervical Spondylotic Myelopathy
- Being tested
- Laminectomy and Laminoplasty
- Keywords
- Myelopathy, Laminectomy, Laminoplasty, Decompression of Spinal Cord, Cervical Spondylosis
- Medical subject headings
- Spinal Cord Diseases, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laminectomy and LaminoplastyProcedure or surgery
Posterior versus anterior approach to laminectomy and laminoplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiological outcomes, functional status and general health related quality of life between anterior vs. posterior approach
Measured: 12 months
Compare the rate of complications between operative patients managed with anterior vs. posterior approaches 6,12 and 24 months following surgery
Measured: 24 months
Secondary outcomes (1)
Compare the outcome of operative treatment at baseline and 6, 12 and 24 months using Nurick score, 30m walk test, mJOA score, NDI and SF-36
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 posted2 Feb 2006 (estimated)
- Study startDec 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)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
- Enrolment
- 321 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AOSpine North America Research Network
- Sponsor type
- Research network
- Collaborators
- AOSpine North America
- Responsible party
- Sponsor
- Investigators
- Michael Fehlings, MD, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285337
- Sponsor's protocol ID
- 06-CSM-03
- Acronym
- CSM
- Status last verified
- Oct 2017
- First submitted
- 1 Feb 2006
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fehlings MG, Smith JS, Kopjar B, Arnold PM, Yoon ST, Vaccaro AR, Brodke DS, Janssen ME, Chapman JR, Sasso RC, Woodard EJ, Banco RJ, Massicotte EM, Dekutoski MB, Gokaslan ZL, Bono CM, Shaffrey CI. Perioperative and delayed complications associated with the surgical treatment of cervical spondylotic myelopathy based on 302 patients from the AOSpine North America Cervical Spondylotic Myelopathy Study. J Neurosurg Spine. 2012 May;16(5):425-32. doi: 10.3171/2012.1.SPINE11467. Epub 2012 Feb 10.
PubMed 22324802Fehlings MG, Jha NK, Hewson SM, Massicotte EM, Kopjar B, Kalsi-Ryan S. Is surgery for cervical spondylotic myelopathy cost-effective? A cost-utility analysis based on data from the AOSpine North America prospective CSM study. J Neurosurg Spine. 2012 Sep;17(1 Suppl):89-93. doi: 10.3171/2012.6.AOSPINE111069.
PubMed 22985375Karadimas SK, Gatzounis G, Fehlings MG. Pathobiology of cervical spondylotic myelopathy. Eur Spine J. 2015 Apr;24 Suppl 2:132-8. doi: 10.1007/s00586-014-3264-4. Epub 2014 Mar 14.
PubMed 24626958Wilson JR, Fehlings MG, Kalsi-Ryan S, Shamji MF, Tetreault LA, Rhee JM, Chapman JR. Diagnosis, heritability, and outcome assessment in cervical myelopathy: a consensus statement. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S76-7. doi: 10.1097/BRS.0b013e3182a7f4bf.
PubMed 23963010Fehlings MG, Wilson JR, Yoon ST, Rhee JM, Shamji MF, Lawrence BD. Symptomatic progression of cervical myelopathy and the role of nonsurgical management: a consensus statement. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S19-20. doi: 10.1097/BRS.0b013e3182a7f4de.
PubMed 23963011Kalsi-Ryan S, Karadimas SK, Fehlings MG. Cervical spondylotic myelopathy: the clinical phenomenon and the current pathobiology of an increasingly prevalent and devastating disorder. Neuroscientist. 2013 Aug;19(4):409-21. doi: 10.1177/1073858412467377. Epub 2012 Nov 30.
PubMed 23204243Shamji MF, Ames CP, Smith JS, Rhee JM, Chapman JR, Fehlings MG. Myelopathy and spinal deformity: relevance of spinal alignment in planning surgical intervention for degenerative cervical myelopathy. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S147-8. doi: 10.1097/BRS.0b013e3182a7f521.
PubMed 23963013Lawrence BD, Shamji MF, Traynelis VC, Yoon ST, Rhee JM, Chapman JR, Brodke DS, Fehlings MG. Surgical management of degenerative cervical myelopathy: a consensus statement. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S171-2. doi: 10.1097/BRS.0b013e3182a7f4ff.
PubMed 23963012Liu S, Lafage R, Smith JS, Protopsaltis TS, Lafage VC, Challier V, Shaffrey CI, Radcliff K, Arnold PM, Chapman JR, Schwab FJ, Massicotte EM, Yoon ST, Fehlings MG, Ames CP. Impact of dynamic alignment, motion, and center of rotation on myelopathy grade and regional disability in cervical spondylotic myelopathy. J Neurosurg Spine. 2015 Dec;23(6):690-700. doi: 10.3171/2015.2.SPINE14414. Epub 2015 Aug 28.
PubMed 26315953Arnold PM, Fehlings MG, Kopjar B, Yoon ST, Massicotte EM, Vaccaro AR, Brodke DS, Shaffrey CI, Smith JS, Woodard EJ, Banco RJ, Chapman JR, Janssen ME, Bono CM, Sasso RC, Dekutoski MB, Gokaslan ZL. Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM). Spine J. 2014 Jan;14(1):65-72. doi: 10.1016/j.spinee.2013.06.016. Epub 2013 Aug 24.
PubMed 23981820Fehlings MG, Wilson JR, Kopjar B, Yoon ST, Arnold PM, Massicotte EM, Vaccaro AR, Brodke DS, Shaffrey CI, Smith JS, Woodard EJ, Banco RJ, Chapman JR, Janssen ME, Bono CM, Sasso RC, Dekutoski MB, Gokaslan ZL. Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study. J Bone Joint Surg Am. 2013 Sep 18;95(18):1651-8. doi: 10.2106/JBJS.L.00589.
PubMed 24048552Tetreault LA, Kopjar B, Vaccaro A, Yoon ST, Arnold PM, Massicotte EM, Fehlings MG. A clinical prediction model to determine outcomes in patients with cervical spondylotic myelopathy undergoing surgical treatment: data from the prospective, multi-center AOSpine North America study. J Bone Joint Surg Am. 2013 Sep 18;95(18):1659-66. doi: 10.2106/JBJS.L.01323.
PubMed 24048553Karpova A, Arun R, Kalsi-Ryan S, Massicotte EM, Kopjar B, Fehlings MG. Do quantitative magnetic resonance imaging parameters correlate with the clinical presentation and functional outcomes after surgery in cervical spondylotic myelopathy? A prospective multicenter study. Spine (Phila Pa 1976). 2014 Aug 15;39(18):1488-97. doi: 10.1097/BRS.0000000000000436.
PubMed 24859570Fehlings MG, Barry S, Kopjar B, Yoon ST, Arnold P, Massicotte EM, Vaccaro A, Brodke DS, Shaffrey C, Smith JS, Woodard E, Banco RJ, Chapman J, Janssen M, Bono C, Sasso R, Dekutoski M, Gokaslan ZL. Anterior versus posterior surgical approaches to treat cervical spondylotic myelopathy: outcomes of the prospective multicenter AOSpine North America CSM study in 264 patients. Spine (Phila Pa 1976). 2013 Dec 15;38(26):2247-52. doi: 10.1097/BRS.0000000000000047.
PubMed 24108289Kopjar B, Tetreault L, Kalsi-Ryan S, Fehlings M. Psychometric properties of the modified Japanese Orthopaedic Association scale in patients with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2015 Jan 1;40(1):E23-8. doi: 10.1097/BRS.0000000000000648.
PubMed 25341993
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. 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
- NCT00285337
- Acronym / sponsor ID
- CSM / 06-CSM-03
- Conditions
- Cervical Spondylotic Myelopathy
- Keywords
- Myelopathy, Laminectomy, Laminoplasty, Decompression of Spinal Cord, Cervical Spondylosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (estimated)
- Lead sponsor
- AOSpine North America Research NetworkResearch network
- Collaborators
- AOSpine North America
- Study start
- Dec 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 2 Feb 2006 (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 purpose of this study is to compare anterior and posterior surgical approach in treatment of CSM in terms of surgical complications and neurological, functional, disease-specific and quality of life outcomes measures.
Secondary aims are to quantify the amount of change pre and post-surgery concerning the same outcome measures; to determine if there are differences in outcomes between posterior surgical techniques (i.e. laminectomy with fusion or laminoplasty) and examine the relationship between baseline MRI and baseline and follow-up neurological and functional outcomes.
Detailed description
Narrowing of the spinal canal by osteophytes, ossification of the posterior longitudinal ligament, or bulging of a large central disk can compress the cervical spinal cord and impinge the spinal nerve roots, resulting in neck pain and various degrees of neurological symptoms and impairment.2 In severe cases, this can lead to stenosis of the cervical spine, resulting in upper motor neuron symptoms in the lower extremity and lower motor neuron symptoms in the upper extremity. When conservative measures such as traction, cervical collar, and postural exercises fail to prevent neurologic progression, surgery may be indicated.
A variety of surgical approaches and procedures are available, and the optimal choice of treatment remains controversial. Surgical procedures designed to decompress the spinal cord and, in some cases, stabilize the spine have been shown to be successful, but there is a persistent percentage of patients who do not improve with surgical intervention.3 Additionally, the potential complications of surgery for CSM may depend on the various methods of surgical management. Historically, cervical laminectomy, a posterior approach, had been regarded as the standard surgical treatment of CSM. However, over the past 20 years, it has been increasingly recognized that laminectomy without fusion is not appropriate for all patients and may result in instability and deformity. Because of the instability caused by laminectomies, alternate surgical approaches such as anterior approaches to the spine and laminoplasty have been developed, and have gained increasing popularity over the years.3 A range of factors must be considered when deciding which surgical technique to use. Surgeons are often challenged with determining the most appropriate technique because there is limited information about whether there is a difference between surgical procedures in terms of clinical and radiographic outcomes, in postoperative complication rates and in functional and quality of life outcomes. Methods of treatment include conservative and surgical management. Among surgically managed patients, an anterior or posterior approach may be employed. Among those managed posteriorly, laminoplasty or laminectomy with fusion are common surgical techniques. With several standards of care available for this population, a better understanding of the corresponding positive and negative outcomes with respect to clinical and patient-centered outcomes is warranted.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergo surgery for symptomatic cervical spondylotic myelopathy with one or or more of the following symptoms: Numb clumsy hands, impairment of gait, bilateral arm parasthesia, L'Hermitte's phenomena
- and one or more of the following signs: corticospinal distribution motor deficits, athropy of hand intrinsic muscles, hyperflexia, positive Hoffman sign, upgoing plantar responses, lower limb spasticity, broad based unstable gait
Key exclusion criteria (10 listed)
- Asymptomatic cervical spondylotic myelopathy
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laminectomy and LaminoplastyPosterior versus anterior approach to laminectomy and laminoplasty | Procedure or surgery | – |
Primary outcome
Clinical and radiological outcomes, functional status and general health related quality of life between anterior vs. posterior approach
Time frame: 12 months
Compare the rate of complications between operative patients managed with anterior vs. posterior approaches 6,12 and 24 months following surgery
Time frame: 24 months
1 secondary outcome
Compare the outcome of operative treatment at baseline and 6, 12 and 24 months using Nurick score, 30m walk test, mJOA score, NDI and SF-36
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 1 Nov 2017.
- Background: PubMed 22324802Fehlings MG, Smith JS, Kopjar B, Arnold PM, Yoon ST, Vaccaro AR, Brodke DS, Janssen ME, Chapman JR, Sasso RC, Woodard EJ, Banco RJ, Massicotte EM, Dekutoski MB, Gokaslan ZL, Bono CM, Shaffrey CI. Perioperative and delayed complications associated with the surgical treatment of cervical spondylotic myelopathy based on 302 patients from the AOSpine North America Cervical Spondylotic Myelopathy Study. J Neurosurg Spine. 2012 May;16(5):425-32. doi: 10.3171/2012.1.SPINE11467. Epub 2012 Feb 10.
- Background: PubMed 22985375Fehlings MG, Jha NK, Hewson SM, Massicotte EM, Kopjar B, Kalsi-Ryan S. Is surgery for cervical spondylotic myelopathy cost-effective? A cost-utility analysis based on data from the AOSpine North America prospective CSM study. J Neurosurg Spine. 2012 Sep;17(1 Suppl):89-93. doi: 10.3171/2012.6.AOSPINE111069.
- Background: PubMed 24626958Karadimas SK, Gatzounis G, Fehlings MG. Pathobiology of cervical spondylotic myelopathy. Eur Spine J. 2015 Apr;24 Suppl 2:132-8. doi: 10.1007/s00586-014-3264-4. Epub 2014 Mar 14.
- Background: PubMed 23963010Wilson JR, Fehlings MG, Kalsi-Ryan S, Shamji MF, Tetreault LA, Rhee JM, Chapman JR. Diagnosis, heritability, and outcome assessment in cervical myelopathy: a consensus statement. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S76-7. doi: 10.1097/BRS.0b013e3182a7f4bf.
- Background: PubMed 23963011Fehlings MG, Wilson JR, Yoon ST, Rhee JM, Shamji MF, Lawrence BD. Symptomatic progression of cervical myelopathy and the role of nonsurgical management: a consensus statement. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S19-20. doi: 10.1097/BRS.0b013e3182a7f4de.
- Background: PubMed 23204243Kalsi-Ryan S, Karadimas SK, Fehlings MG. Cervical spondylotic myelopathy: the clinical phenomenon and the current pathobiology of an increasingly prevalent and devastating disorder. Neuroscientist. 2013 Aug;19(4):409-21. doi: 10.1177/1073858412467377. Epub 2012 Nov 30.
- Background: PubMed 23963013Shamji MF, Ames CP, Smith JS, Rhee JM, Chapman JR, Fehlings MG. Myelopathy and spinal deformity: relevance of spinal alignment in planning surgical intervention for degenerative cervical myelopathy. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S147-8. doi: 10.1097/BRS.0b013e3182a7f521.
- Background: PubMed 23963012Lawrence BD, Shamji MF, Traynelis VC, Yoon ST, Rhee JM, Chapman JR, Brodke DS, Fehlings MG. Surgical management of degenerative cervical myelopathy: a consensus statement. Spine (Phila Pa 1976). 2013 Oct 15;38(22 Suppl 1):S171-2. doi: 10.1097/BRS.0b013e3182a7f4ff.
- Background: PubMed 26315953Liu S, Lafage R, Smith JS, Protopsaltis TS, Lafage VC, Challier V, Shaffrey CI, Radcliff K, Arnold PM, Chapman JR, Schwab FJ, Massicotte EM, Yoon ST, Fehlings MG, Ames CP. Impact of dynamic alignment, motion, and center of rotation on myelopathy grade and regional disability in cervical spondylotic myelopathy. J Neurosurg Spine. 2015 Dec;23(6):690-700. doi: 10.3171/2015.2.SPINE14414. Epub 2015 Aug 28.
- Results publication: PubMed 23981820Arnold PM, Fehlings MG, Kopjar B, Yoon ST, Massicotte EM, Vaccaro AR, Brodke DS, Shaffrey CI, Smith JS, Woodard EJ, Banco RJ, Chapman JR, Janssen ME, Bono CM, Sasso RC, Dekutoski MB, Gokaslan ZL. Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM). Spine J. 2014 Jan;14(1):65-72. doi: 10.1016/j.spinee.2013.06.016. Epub 2013 Aug 24.
- Results publication: PubMed 24048552Fehlings MG, Wilson JR, Kopjar B, Yoon ST, Arnold PM, Massicotte EM, Vaccaro AR, Brodke DS, Shaffrey CI, Smith JS, Woodard EJ, Banco RJ, Chapman JR, Janssen ME, Bono CM, Sasso RC, Dekutoski MB, Gokaslan ZL. Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study. J Bone Joint Surg Am. 2013 Sep 18;95(18):1651-8. doi: 10.2106/JBJS.L.00589.
- Results publication: PubMed 24048553Tetreault LA, Kopjar B, Vaccaro A, Yoon ST, Arnold PM, Massicotte EM, Fehlings MG. A clinical prediction model to determine outcomes in patients with cervical spondylotic myelopathy undergoing surgical treatment: data from the prospective, multi-center AOSpine North America study. J Bone Joint Surg Am. 2013 Sep 18;95(18):1659-66. doi: 10.2106/JBJS.L.01323.
Related trials for Cervical Spondylotic Myelopathy
Not yet recruitingObservational study
Biomarkers of Cervical Spondylotic Myelopathy
Cervical Spondylotic Myelopathy
Not yet recruitingObservational study
A Multicenter Registry-Based Study Across the Spectrum of Degenerative Cervical Myelopathy
Degenerative Cervical Myelopathy, Non-myelopathic Degenerative Cervical Cord Compression
Active, not recruiting
Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament
Ossification of Posterior Longitudinal Ligament, Cervical Spondylosis With Myelopathy
RecruitingObservational study
Validity of the Turkish Translation of the Modified JOA
Spondylosis, Cervical, Spinal Cord Compression
Active, not recruiting
Cervical Spondylotic Myelopathy Surgical Trial
Cervical Spondylosis With Myelopathy
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 Toronto
13 sites in 2 countries: 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 AOSpine North America Research Network at 13 sites in 2 countries.
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 2 inclusion and 10 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 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, 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?
Clinical and radiological outcomes, functional status and general health related quality of life between anterior vs. posterior approach (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT00285337, which also lists 43 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 1 Nov 2017.