Guideline Title
Anterior cervical surgery for the treatment of cervical degenerative myelopathy.
Bibliographic Source(s)
Matz PG, Holly LT, Mummaneni PV, Anderson PA, Groff MW, Heary RF, Kaiser MG, Ryken TC, Choudhri TF, Vresilovic EJ, Resnick DK, Joint Section on Disorders of the Spine and Peripheral Nerves [trunc]. Anterior cervical surgery for the treatment of cervical degenerative myelopathy. J Neurosurg Spine 2009 Aug;11(2):170-3. [7 references] PubMed ![External Web Site Policy](https://webarchive.library.unt.edu/web/20121007060457im_/http://www.guidelines.gov/images/icon_externallink.gif) |
Guideline Status
This is the current release of the guideline.
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Disease/Condition(s)
Cervical degenerative myelopathy (cervical spondylotic myelopathy)
Guideline Category
Treatment
Clinical Specialty
Chiropractic
Family Practice
Geriatrics
Internal Medicine
Neurological Surgery
Neurology
Orthopedic Surgery
Physical Medicine and Rehabilitation
Preventive Medicine
Sports Medicine
Intended Users
Physicians
Guideline Objective(s)
- To address questions regarding the therapy, diagnosis, and prognosis of cervical degenerative disease using an evidence-based approach
- To examine the efficacy of anterior cervical surgery for the treatment of cervical spondylotic myelopathy (CSM)
Target Population
Patients with cervical spondylotic myelopathy
Interventions and Practices Considered
- Anterior cervical surgery (surgical decompression)
- Nonoperative therapy (i.e., prolonged immobilization in a stiff cervical collar, "low-risk" activity modification or bed rest, and anti-inflammatory medications)
Note: Timing of surgery was considered, but there is insufficient evidence to make a recommendation.
Major Outcomes Considered
Functional improvement in terms of:
- Modified Japanese Orthopaedic Association (mJOA) score
- 10 meter walk
- Activities of daily living (ADLs)
- Neurological Rating Assessment
- Electrophysiological potential
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Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
Search Criteria
The expert group conducted a computerized search of the Cochrane Database and of the National Library of Medicine between 1966 and 2007 using MeSH headings. The search headings included the following terms: "cervical vertebrae," "outcome assessment," "cervical spondylosis," "myelopathy," "cervical spondylotic myelopathy," "controlled clinical trial," "spinal osteophytosis," and "spinal cord disease." The total number of citations was 1,689 when terms were combined. One study (a systematic review) was found in the Cochrane database. Of these articles, the group analyzed only those in the English language. They reviewed the abstracts of these citations and selected applicable articles. The references cited in the qualifying articles were also reviewed to gather any other applicable manuscripts published between 1966 and 2007. Five references were found that provided potentially high-quality evidence (see Table 1 in the original guideline document.)
Number of Source Documents
Five references were found that provided potentially high-quality evidence.
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Strength of the Evidence
Class I: Evidence evolved from well-designed randomized controlled trials (RCTs).
Class II: Evidence arose from RCTs with design problems or from well-designed cohort studies.
Class III: Evidence arose from case series or poorly designed cohort studies.
Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Quality of Evidence
The guidelines group assembled an evidentiary table summarizing the quality of evidence.
The mainstay of any evidence-based review lies in the assessment of the quality of strength of the data. The group assessed the methodology of each manuscript carefully and assessed each study according to its relevant category—diagnosis, therapy, prognosis, or harm. The group applied a weighting scheme according to the methods delineated by Sackett and colleagues. After review of the study methods, the group determined how well each individual study met the validity requirements within its category and assigned a class to the study. In keeping with prior surgical guidelines, a 3-class system (Classes I, II, and III) was used (see the "Rating Scheme for the Strength of the Evidence" field).
It was the group's conclusion that expert opinion and case reports did not add significantly to the evidence used for the formulation of recommendations and should not be separately classified.
When disagreement arose as to the strength of evidence (that is, determining how well the methods conformed to the weighting scheme), the group resolved said disagreement by expert consensus within itself. To avoid the undue influence of a single individual, each member had the opportunity to list the reason(s) why a study should be downgraded or upgraded. Group members then prioritized each reason. If a reason had low priority, it was eliminated. Ultimately, there was convergence of opinion within the group. The result was unanimity to support publicly the assessment of the quality of evidence and the strength of the guidelines despite potential individual reservations regarding specific details.
Methods Used to Formulate the Recommendations
Expert Consensus (Consensus Development Conference)
Description of Methods Used to Formulate the Recommendations
In March 2006, the Joint Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons/Congress of Neurological Surgeons compiled an expert group to perform an evidence-based review of the clinical literature on the management of cervical degenerative spine disease. Comprising the group were spinal neurosurgeons and orthopedic surgeons active in the Joint Section and/or the North American Spine Society. This combination of specialties ensured the comprehensive participation of both surgical specialties. At least half of the group had participated in prior guidelines development, and several had completed the evidence-based course developed by the North American Spine Society. The multiple recommendations represent the product of this group with input from the Guidelines Committee of the American Association of Neurological Surgeons/Congress of Neurological Surgeons.
Formulation and Strength of Recommendations
The group formulated recommendations using expert consensus in a consensus development conference. After assessment of the quality and strength of evidence, the assigned subgroup summarized the studies leading to the basis of the Scientific Foundation section of each chapter. In general, if high-quality (Class I or II) data were available on a particular topic, poorer quality evidence was only briefly summarized. If no high-quality evidence existed, Class III data formed the basis of the scientific foundation. Based on the quality and strength of data, each subgroup formulated initial treatment recommendations. Each subgroup presented these to the entire group whose membership included active members of the Congress of Neurological Surgeons, the American Association of Neurological Surgeons, the North American Spine Society, and the American Academy of Orthopedic Surgery. The presentation was a plenary session acting as a consensus development conference from which final recommendations arose.
The group gave each recommendation a grade for strength based on the quality of the underlying studies. Grading was based on the methods of the Scottish Intercollegiate Guidelines Network and also mirrored that used by the Oxford Centre for Evidence-Based Medicine (www.cebm.net ) (see the "Rating Scheme for the Strength of the Recommendations" field).
Rating Scheme for the Strength of the Recommendations
Strength of the Recommendations
Grade A: Recommendations based on consistent Class I studies.
Grade B: Recommendations based on a single Class I study or consistent Class II studies.
Grade C: Recommendations based on a single Class II study.
Grade D: Recommendations based on Class III or weaker data, or based on inconsistent data.
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation
Validation was done through peer review by the Joint Guidelines Committee of the American Association of Neurological Surgeons/Congress of Neurological Surgeons and through external peer review prior to publication.
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Major Recommendations
The rating schemes used for the strength of the evidence (Class I-III) and the grades of recommendations (A-D) are defined at the end of the "Major Recommendations" field.
Recommendations
Indications
It is recommended that mild cervical spondylotic myelopathy (CSM) be treated in the short term (3 years) either with surgical decompression or with nonoperative therapy (prolonged immobilization in a stiff cervical collar, "low-risk" activity modification or bed rest, and antiinflammatory medications) based on patient preference (Quality of evidence, Class II; Strength of recommendation, C). More severe CSM should be treated with surgical decompression with benefits being maintained a minimum of 5 years and as long as 15 years postoperatively (Quality of evidence, Class III; Strength of recommendation, D).
Methods
These will be addressed in the guideline on cervical surgical techniques for the treatment of CSM.
Timing
There is insufficient evidence to make a recommendation on timing.
Summary
Currently, there exists no Class I evidence to assess the efficacy of anterior surgery for mild or severe CSM. Class II studies have indicated improvement with both operative and nonoperative therapy for mild CSM. Controlled clinical trials comparing the 2 approaches in the setting of mild CSM have been flawed but indicated equivalency between surgery and nonoperative therapy in 1 group of studies derived from the same patient population (Class II), and greater benefit for surgery in a different trial that was part of a larger trial (Class III). Current evidence (Class II) suggests that mild CSM (modified Japanese Orthopedic Association [mJOA] scale score >12) may be managed with surgery or nonoperative management over the short term (3 years). However, more severe CSM (mJOA scale score <12) appears to respond more readily to surgery (Class III).
The shortcoming of any evidence-based approach is that the recommendations are only as strong as the underlying studies. Although the studies systematically reviewed in this article indicate a stable time course for patients with mild symptoms, several questions and concerns arise. First, a mJOA score of 12 may not necessarily be considered mild disease as it was in the underlying studies. In general, patients with an mJOA score of 12 have a moderate impairment in gait, bladder, or hand function (motor or sensory), or a combination of disabilities. Clinical deterioration from this point may be ominous in terms of the functional ability. Secondly, even if CSM is stable without surgical correction for 3 years, what about the probability of deterioration after 3 years? If the underlying problem is not corrected, deterioration after 3 years may be an issue. Once again, the limits of the evidence-based approach are that it cannot specifically answer this question if it has not been studied. Other systematic reviews in this series on laminectomy, laminoplasty, laminectomy and fusion, and anterior surgery indicate clinical improvement after surgery over several years' duration. This segues into the third issue: the absence of Class 1 evidence on this subject and how to ameliorate that deficiency. It is probably impossible to design a practical study that would provide Class 1 evidence; however, Class 2 evidence could potentially be gained from a well-structured case-control series based on a prospective registry.
Definitions:
Strength of the Evidence
Class I: Evidence evolved from well-designed randomized controlled trials (RCTs).
Class II: Evidence arose from RCTs with design problems or from well-designed cohort studies.
Class III: Evidence arose from case series or poorly designed cohort studies.
Strength of the Recommendations
Grade A: Recommendations based on consistent Class I studies.
Grade B: Recommendations based on a single Class I study or consistent Class II studies.
Grade C: Recommendations based on a single Class II study.
Grade D: Recommendations based on Class III or weaker data, or based on inconsistent data.
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Evidence Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").
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Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
Appropriate use of anterior cervical surgery for treatment of patients with cervical spondylotic myelopathy (CSM)
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Qualifying Statements
- During guideline development, the group commonly encountered unsophisticated or poorly designed comparative methods in clinical trials. The most common flaw was the lack of a control group or the utilization of historical controls. Other common flaws were invalid outcome measures, and the lack either of randomization or blinding of outcome assessors. Specific examples are provided in the text of each topic. At the conclusion of each chapter are suggestions for future areas of study and ideas to improve the quality of clinical research.
- With each recommendation comes the risk of conformational bias. The recommendation of a therapeutic option presumes that functional and economic preferences have been determined. Reliable and valid outcome measures help in this respect. It is hoped that such functional and economic outcome measures represent the values important to the patient and society and less the practitioner. By focusing attention on outcome measures in each study, the values of the patient and society are represented in these guidelines.
- To minimize any specialty bias, spinal surgeons from both orthopedic and neurosurgery departments participated in the creation of these guidelines. However, although invited, nonsurgical stakeholders did not participate—a circumstance that some might argue would predispose to conformational bias toward strong surgical recommendations. It is hoped in the future that nonsurgical stakeholders will participate. During this process, the entire group made a concerted effort to be unprejudiced. Many authors acknowledged that poor quality or controversial data often formed the basis of their predetermined ideas regarding standard treatment. It is expected that certain practitioners may disagree with the recommendations. However, with careful review of the scientific foundation, the critically thoughtful reader should find the recommendations warranted.
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Implementation of the Guideline
Description of Implementation Strategy
An implementation strategy was not provided.
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Institute of Medicine (IOM) National Healthcare Quality Report Categories
IOM Care Need
Getting Better
Living with Illness
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Identifying Information and Availability
Bibliographic Source(s)
Matz PG, Holly LT, Mummaneni PV, Anderson PA, Groff MW, Heary RF, Kaiser MG, Ryken TC, Choudhri TF, Vresilovic EJ, Resnick DK, Joint Section on Disorders of the Spine and Peripheral Nerves [trunc]. Anterior cervical surgery for the treatment of cervical degenerative myelopathy. J Neurosurg Spine 2009 Aug;11(2):170-3. [7 references] PubMed ![External Web Site Policy](https://webarchive.library.unt.edu/web/20121007060457im_/http://www.guidelines.gov/images/icon_externallink.gif) |
Adaptation
Not applicable: The guideline was not adapted from another source.
Guideline Developer(s)
American Association of Neurological Surgeons - Medical Specialty Society
Congress of Neurological Surgeons - Professional Association
Source(s) of Funding
Administrative costs of this project were funded by the Joint Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons and Congress of Neurological Surgeons.
Guideline Committee
The Joint Section on Disorders of the Spine and Peripheral Nerves of the American Association of Neurological Surgeons and Congress of Neurological Surgeons Expert Group
Composition of Group That Authored the Guideline
Authors: Paul G. Matz, M.D., Division of Neurological Surgery, University of Alabama, Birmingham, Alabama; Langston T. Holly, M.D., Division of Neurosurgery, David Geffen School of Medicine, University of California at Los Angeles; Praveen V. Mummaneni, M.D., Department of Neurosurgery, University of California at San Francisco, California; Paul A. Anderson, M.D, Department of Orthopedic Surgery, University of Wisconsin, Madison, Wisconsin; Michael W. Groff, M.D., Department of Neurosurgery, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Massachusetts; Robert F. Heary, M.D., Department of Neurosurgery, University of Medicine and Dentistry of New Jersey—New Jersey Medical School, Newark, New Jersey; Michael G. Kaiser, M.D., Department of Neurological Surgery, Neurological Institute, Columbia University, New York, New York; Timothy C. Ryken, M.D., Department of Neurosurgery, University of Iowa Hospitals and Clinics, Iowa City, Iowa; Tanvir F. Choudhri, M.D., Department of Neurosurgery, Mount Sinai School of Medicine, New York, New York; Edward J. Vresilovic, M.D., Ph.D., Department of Orthopaedic Surgery, Milton S. Hershey Medical Center, Pennsylvania State College of Medicine, Hershey, Pennsylvania; Daniel K. Resnick, M.D., Department of Neurological Surgery, University of Wisconsin, Madison, Wisconsin
Financial Disclosures/Conflicts of Interest
No author received payment or honorarium for time devoted to this project. Dr. Resnick owns stock in Orthovita. Dr. Matz receives support from the Kyphon Grant for Thoracolumbar Fracture Study, and an advisory honorarium from Synthes for the cadaver laboratory. Dr. Heary receives support from DePuy Spine and Biomet Spine, and receives royalties from DePuy Spine and Zimmer Spine. Dr. Groff is a consultant for DePuy Spine. Dr. Mummaneni is a consultant for and receives university grants from DePuy Spine and Medtronic, Inc., and is a patent holder in DePuy Spine. Dr. Anderson is an owner of, consultant for, and stockholder of Pioneer Surgical Technology; a consultant for and receives non–study related support from Medtronic, Inc.; and is a patent holder in Stryker. The authors report no other conflicts of interest concerning the materials or methods used in this study or the findings specified in this paper.
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available from the Journal of Neurosurgery Web site .
Print copies: Available from the Journal of Neurosurgery Publishing Group, 1224 Jefferson Park Avenue, Suite 450, Charlottesville, Virginia 22903, USA. Telephone: 434-924-5503
Availability of Companion Documents
The following is available:
- Introduction and methodology: guidelines for the surgical management of cervical degenerative disease. J Neurosurg Spine. 2009 Aug;11(2):101-3. Electronic copies: Available from the Journal of Neurosurgery Web site
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NGC Status
This NGC summary was completed by ECRI Institute on February 14, 2011. The information was verified by the guideline developer on March 20, 2011.
Copyright Statement
This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
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