Guideline Title
Techniques for anterior cervical decompression for radiculopathy.
Bibliographic Source(s)
Matz PG, Ryken TC, Groff MW, Vresilovic EJ, Anderson PA, Heary RF, Holly LT, Kaiser MG, Mummaneni PV, Choudhri TF, Resnick DK, Joint Section on Disorders of the Spine and Peripheral Nerves [trunc]. Techniques for anterior cervical decompression for radiculopathy. J Neurosurg Spine 2009 Aug;11(2):183-97. [42 references] PubMed |
Guideline Status
This is the current release of the guideline.
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Disease/Condition(s)
Cervical degenerative radiculopathy (cervical disc degeneration)
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 use evidence-based medicine to identify the best techniques for anterior cervical nerve root decompression
Target Population
Patients with cervical degenerative radiculopathy
Interventions and Practices Considered
- Anterior cervical discectomy (ACD)
- Anterior cervical discectomy with fusion (ACDF)
- Anterior cervical plating (anterior cervical discectomy and fusion with instrumentation [ACDFI])
- Cervical arthroplasty
Note: Timing of surgery was considered, but there is insufficient evidence to make a recommendation.
Major Outcomes Considered
- Fusion rates
- Kyphosis
- Range of motion
- Graft complications
- Clinical outcomes
- Length of stay (LOS)
- Operative time
- Blood loss
- Improvement in arm and neck pain
- Functional improvement
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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 searched the National Library of Medicine (PubMed) and the Cochrane Database for the period from 1966 through 2007 using keywords and associated MeSH subject headings. A search of "anterior cervical discectomy" yielded 436 references. "Anterior cervical diskectomy" plus "fusion" yielded 367 references. "Anterior cervical diskectomy" plus "fixation" yielded 92 references while "anterior cervical diskectomy" plus "plating" yielded 125 references. Adding to the above terms was the term "outcome," which yielded a total of 607 references. Adding "technique" yielded 386 references. Finally, using "anterior" and "cervical" with either "fusion" or "outcome" yielded 1,073 references. After combining the databases and eliminating duplicate references, 2,155 articles remained. The group reviewed titles and abstracts with attention to titles addressing trials comparing different techniques; 1 Cochrane database review addressed the subject as well. Outcomes of interest, both short and long term, included length of stay (LOS), operative time, blood loss, improvement in arm and neck pain, and functional improvement.
The expert group selected articles if they included a clinical comparison of 2 or more treatment options and excluded articles that contained information on only a single technique. Preference was given to randomized controlled trials (RCTs), systematic reviews, or studies containing prospective data. Evidentiary tables (See Tables 1–3 in the original guideline document) were compiled based on the resulting 30 studies that met inclusion criteria. Ten studies and 1 systematic review examined anterior cervical discectomy (ACD) compared with anterior cervical discectomy with fusion (ACDF) (see Table 1 in the original guideline document). Sixteen studies and 2 systematic reviews addressed anterior cervical discectomy and fusion with instrumentation (ACDFI) (plating) versus ACDF without plating (see Table 2 in the original guideline document). The authors of 4 studies examined dynamic plating versus static plating (see Table 3 in the original guideline document). For arthroplasty, the search protocol was similar to above. Search terms included "arthroplasty" and "spine" and "cervical vertebra," which yielded 88 references, and "arthroplasty" and "spine," which yielded 280 references. After reviewing abstracts and titles, the expert group examined 10 studies that reported outcomes of arthroplasty compared to preoperative function or ACDF (see Table 4 in the original guideline document).
Number of Source Documents
30 studies that met inclusion criteria were included in evidence tables.
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
1-Level Cervical Disc Degeneration. Both anterior cervical discectomy (ACD) and anterior cervical discectomy with fusion (ACDF) are recommended as equivalent treatment strategies for 1-level cervical disc degeneration with respect to clinical outcome measures such as visual analog scale (VAS) pain score, Odom's criteria, the McGill Pain Questionnaire, 36-Item Short Form Health Survey (SF-36), and arm pain (Quality of evidence, Class II, Strength of recommendation, C). There is conflicting Class II evidence as to whether ACDF relieves overall neck pain associated with 1-level cervical disc degeneration better than ACD.
Methods
ACDF Compared to ACD. Both ACD and ACDF are recommended as equivalent treatment strategies for 1-level cervical disc degeneration with respect to clinical outcome measures such as VAS pain score, Odom's criteria, the McGill Pain Questionnaire, SF-36, and arm pain (Quality of evidence, Class I; Strength of recommendation, C). There is conflicting Class II evidence as to whether ACDF relieves overall neck pain associated with 1-level cervical disc degeneration better than ACD. ACDF is recommended over ACD for a more rapid reduction of neck and arm pain (Quality of evidence, Class III; Strength of recommendation, D), although functional outcomes may be similar. ACDF is also recommended over ACD as a means to reduce the risk of kyphosis and increase fusion rate (Quality of evidence, Class II; Strength of recommendation, C). ACDF is not recommended as a lasting means of increasing foraminal or disc height compared to ACD (Quality of evidence, Class II; Strength of recommendation, C).
Indications
- 2-Level Cervical Disc Degeneration. Anterior cervical plating (ACDF with instrumentation [ACDFI]) is recommended over ACDF to improve arm pain in the treatment of 2-level cervical disc degeneration (Quality of evidence, Class II; Strength of recommendation, C). Plating does not improve other clinical outcome parameters with respect to 2-level disease.
- 1-Level Cervical Disc Degeneration. With respect to 1-level cervical disc degeneration, the addition of a cervical plate is recommended if the goal is to reduce the risk of pseudarthrosis and graft problems (Quality of evidence, Class III; Strength of recommendation, D) and to maintain lordosis (Quality of evidence, Class II; Strength of recommendation, C) but not necessarily to improve clinical outcome alone (Quality of evidence, Class II; Strength of recommendation, B). Cervical arthroplasty is recommended as an alternative to ACDF in selected patients for control of neck and arm pain (Quality of evidence, Class II; Strength of recommendation, B).
Methods
- Plating Compared to No Plating. Anterior cervical discectomy and fusion with instrumentation (ACDFI) is recommended over ACDF to improve arm pain in the treatment of 2-level cervical disc degeneration (Quality of evidence, Class II; Strength of recommendation, C). Plating does not improve other clinical outcome parameters with respect to 2-level disease. With respect to 1-level cervical disc degeneration, the addition of a cervical plate is recommended if the goal is to reduce the risk of pseudarthrosis and graft problems (Quality of evidence, Class III; Strength of recommendation, D) and to maintain lordosis (Quality of evidence, Class II; Strength of recommendation, C) but not necessarily to improve clinical outcome alone (Quality of evidence, Class II; Strength of recommendation, B).
- Cervical Arthroplasty. Cervical arthroplasty is recommended as an alternative to ACDF in selected patients for control of neck and arm pain (Quality of evidence, Class II; Strength of recommendation, B).
Timing
There is insufficient evidence to make a recommendation on timing.
Summary
Despite the abundance of studies, there exists no Class I evidence to assess the efficacy of adding fusion or plate fixation to ACD. Furthermore, there is no Class I evidence indicating that arthroplasty is superior to ACDF. Class II evidence indicates that ACD and ACDF are equivalent treatment strategies for cervical disc degeneration with regard to the clinical outcomes as measured by the VAS, McGill Questionnaire, and Odom's criteria. Two Class II studies demonstrated equivalency for arm pain, and conflicting evidence was demonstrated for neck pain with 1 Class II study showing equivalence and another Class II study showing ACDF to be superior. The time to relief of neck or arm pain is shorter after ACDF (Class III). The ACDF technique is associated with better fusion (Class II) and avoidance of postoperative kyphosis (Class II).
Class II evidence indicates that plate fixation does not improve long-term outcome in patients with 1-level cervical disc degeneration but does improve arm pain associated with 2-level disc degeneration (Class II). The results in 2 Class II and 6 Class III studies indicate equivalent clinical and functional outcome with or without plate fixation. The use of a cervical plate improves cervical lordosis (Class II), reduces the risk of pseudarthrosis (Class III), and reduces the incidence of graft-related complications (Class III), but increases surgical blood loss (Class II). Dynamic plate fixation has not been shown to increase fusion rates compared to rigid plates (Class III). Class II evidence indicates that cervical arthroplasty is as effective as ACDF with plating for control of neck and arm pain in selected patients.
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 the recommendations (see "Major Recommendations").
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Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
Appropriate use of surgical techniques for anterior cervical decompression in patients with radiculopathy
Potential Harms
Complications of surgery, including graft-related complications, surgical blood loss, screw failure, and dysphagia
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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, Ryken TC, Groff MW, Vresilovic EJ, Anderson PA, Heary RF, Holly LT, Kaiser MG, Mummaneni PV, Choudhri TF, Resnick DK, Joint Section on Disorders of the Spine and Peripheral Nerves [trunc]. Techniques for anterior cervical decompression for radiculopathy. J Neurosurg Spine 2009 Aug;11(2):183-97. [42 references] PubMed |
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; Timothy C. Ryken, M.D., Department of Neurosurgery, University of Iowa Hospitals and Clinics, Iowa City, Iowa; Michael W. Groff, M.D., Department of Neurosurgery, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Massachusetts; Edward J. Vresilovic, M.D., Ph.D., Department of Orthopedic Surgery, Milton S. Hershey Medical Center, Pennsylvania State College of Medicine, Hershey, Pennsylvania; Paul A. Anderson, M.D., Department of Orthopedic Surgery, University of Wisconsin, Madison, Wisconsin; Robert F. Heary, M.D., Department of Neurosurgery, University of Medicine and Dentistry of New Jersey—New Jersey Medical School, Newark, New Jersey; Langston T. Holly, M.D., Division of Neurosurgery, David Geffen School of Medicine, University of California at Los Angeles, California; Michael G. Kaiser, M.D., Department of Neurological Surgery, Neurological Institute, Columbia University, New York, New York; Praveen V. Mummaneni, M.D., Department of Neurosurgery, University of California at San Francisco, California; Tanvir F. Choudhri, M.D., Department of Neurosurgery, Mount Sinai School of Medicine, New York, New York; 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 .
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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