Clinical trial NCT00285337: Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
Official title: An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Spondylotic Myelopathy
Keywords: Myelopathy
Laminectomy
Laminoplasty
Decompression of Spinal Cord
Cervical Spondylosis
Lead sponsor: AOSpine North America Research Network
Sponsor class: NETWORK
Collaborators: name: AOSpine North America
First posted: 2006-02-02
Enrollment: 321
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

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 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

Primary outcomes:
measure: Clinical and radiological outcomes, functional status and general health related quality of life between anterior vs. posterior approach
timeFrame: 12 months
measure: Compare the rate of complications between operative patients managed with anterior vs. posterior approaches 6,12 and 24 months following surgery
timeFrame: 24 months
Secondary outcomes:
measure: 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
timeFrame: 24 months
Other outcomes:
Locations:
city: Thornton
country: United States
facility: Spine Education and Research Institute
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indianda Spine Group
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Thomas Jefferson University and Rothman Institure Orthopaedics
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Universty of Utah
state: Utah
city: Charlottesville
country: United States
facility: University Of Virginia
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Michael Fehlings, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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