An observational study in Cervical Spondylotic Myelopathy, sponsored by AOSpine North America Research Network. Completed at 13 sites in 2 countries. Per ClinicalTrials.gov, last updated 2017-11-01.
Sponsored by AOSpine North America Research Network · Observational
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.
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.
206 studies on the registry are indexed under Spinal Cord Diseases; 55 are open to participants now.
This study's planned enrollment of 321 is above the median of 100 across 59 observational studies indexed under Spinal Cord Diseases.
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Posterior versus anterior approach to laminectomy and laminoplasty
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
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
The record gives a start of Dec 2005 and a completion of Nov 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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AOSpine North America Research Network