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Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy (CSM)

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ClinicalTrials.gov Identifier: NCT00285337
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
AOSpine North America
Information provided by (Responsible Party):
AOSpine North America Research Network

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment
Cervical Spondylotic Myelopathy Procedure: Laminectomy and Laminoplasty

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
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Study Type : Observational
Estimated Enrollment : 321 participants
Official Title: An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
Study Start Date : December 2005
Actual Study Completion Date : November 2007

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Groups and Cohorts
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Intervention Details:
  • Procedure: Laminectomy and Laminoplasty
    Posterior versus anterior approach to laminectomy and laminoplasty

Outcome Measures
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Primary Outcome Measures :
  1. Clinical and radiological outcomes, functional status and general health related quality of life between anterior vs. posterior approach [ Time Frame: 12 months ]
  2. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Asymptomatic cervical spondylotic myelopathy
  • previous surgery for CSM
  • Active infection
  • Neoplastic disease
  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Trauma
  • Concomitant lumbar stenosis
  • Not referred for surgical consultation
  • Participating in other trials or unlikely to attend follow-ups
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285337


Locations
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United States, Colorado
Spine Education and Research Institute
Thornton, Colorado, United States, 80229
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Indiana
Indianda Spine Group
Indianapolis, Indiana, United States, 46260
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Thomas Jefferson University and Rothman Institure Orthopaedics
Philadelphia, Pennsylvania, United States, 19107
United States, Utah
Universty of Utah
Salt Lake City, Utah, United States, 84108
United States, Virginia
University Of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
AOSpine North America Research Network
AOSpine North America
Investigators
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Principal Investigator: Michael Fehlings, MD, PhD University of Toronto
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AOSpine North America Research Network
ClinicalTrials.gov Identifier: NCT00285337    
Other Study ID Numbers: 06-CSM-03
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Keywords provided by AOSpine North America Research Network:
Myelopathy
Laminectomy
Laminoplasty
Decompression of Spinal Cord
Cervical Spondylosis
Additional relevant MeSH terms:
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Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases