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

This study has been completed.
Sponsor:
Collaborator:
AOSpine North America
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00285337
First received: February 1, 2006
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Cervical Spondylotic Myelopathy
Procedure: Laminectomy and Laminoplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 321
Study Start Date: December 2005
Study Completion Date: November 2007
Intervention Details:
    Procedure: Laminectomy and Laminoplasty
    Posterior versus anterior approach to 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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285337

Locations
United States, Colorado
Spine Education and Research Institute
Thorton, 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
Mayo Clinic
Rochester, Maryland, United States, 55905
United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
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
AO Clinical Investigation and Documentation
AOSpine North America
Investigators
Principal Investigator: Michael Fehlings, MD, PhD University of Toronto
  More Information

Publications:

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00285337     History of Changes
Other Study ID Numbers: 06-CSM-03
Study First Received: February 1, 2006
Last Updated: November 27, 2013
Health Authority: Canada: Health Canada

Keywords provided by AO Clinical Investigation and Documentation:
Myelopathy
Laminectomy
Laminoplasty
Decompression of Spinal Cord
Cervical Spondylosis

Additional relevant MeSH terms:
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014