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Complete Summary

GUIDELINE TITLE

Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: lumbar fusion for disc herniation and radiculopathy.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

COMPLETE SUMMARY CONTENT

 
SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Degenerative disease of the lumbar spine: disc herniation and radiculopathy

GUIDELINE CATEGORY

Management
Treatment

CLINICAL SPECIALTY

Internal Medicine
Neurological Surgery
Neurology
Orthopedic Surgery
Physical Medicine and Rehabilitation

INTENDED USERS

Health Plans
Managed Care Organizations
Physicians

GUIDELINE OBJECTIVE(S)

To examine the medical evidence concerning the role of lumbar fusion in the operative treatment of patients with radiculopathy and back pain caused by a herniated lumbar intervertebral disc

TARGET POPULATION

Patients with disc herniation and radiculopathy

INTERVENTIONS AND PRACTICES CONSIDERED

  1. Lumbar spinal fusion as a surgical adjunct in selected patients
  2. Reoperative discectomy in selected patients
  3. Reoperative discectomy combined with fusion in selected patients

Note: Lumbar spinal fusion is not recommended as routine treatment following primary disc excision in patients with a herniated lumbar disc causing radiculopathy.

MAJOR OUTCOMES CONSIDERED

Effectiveness of treatment in terms of pain relief, return to work one year following surgery, pain recurrence, return to and maintenance of preoperative level of function, and patient satisfaction

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

A computerized search of the database of the National Library of Medicine from 1966 to November 2003 was conducted using the search terms "spinal fusion and disc herniation," "lumbar disc herniation and surgery and outcome," and "lumbar disc herniation and fusion." The search was restricted to the English language. This yielded a total of 389 references. The titles and abstracts of each of these references were reviewed, and papers not concerned with the use of fusion with lumbar disc herniations were discarded. References were identified that provided either direct or supporting evidence relevant to the use of fusion as a treatment for lumbar disc herniations. These papers were pulled and reviewed, and relevant references from their bibliographies were identified. Relevant papers providing Class III or better evidence are summarized in Table 1 of the original guideline document. Significant supportive data are provided by other references listed in the bibliography of the original guideline.

NUMBER OF SOURCE DOCUMENTS

12 papers providing Class II or better evidence are summarized in Table 1 of the original guideline document.

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Classes of Evidence

Class I Evidence from one or more well-designed, randomized controlled clinical trials, including overviews of such trials

Class II Evidence from one or more well-designed comparative clinical studies, such as nonrandomized cohort studies, case-control studies, and other comparable studies, including less well-designed randomized controlled trials

Class III Evidence from case series, comparative studies with historical controls, case reports, and expert opinion as well as significantly flawed randomized controlled trials

METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The group culled through literally thousands of references to identify the most scientifically robust citations available concerning each individual topic. Not every reference identified is cited. In general, if high-quality (Class I or II) medical evidence was available on a particular topic, poorer-quality evidence was only briefly summarized and rarely included in the evidentiary tables. If no high-quality evidence existed, or if there was significant disagreement between similarly classified evidence sources, then the Class III and supporting medical evidence were discussed in greater detail. If multiple reports were available that provided similar information, a few were chosen as illustrative examples.

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

In January 2003, a group was formed at the request of the leadership of the Congress of Neurological Surgeons (CNS) by the executive committee of the American Association of Neurological Surgeons/CNS Joint Section on Disorders of the Spine and Peripheral Nerves to perform an evidence-based review of the literature on lumbar fusion procedures for degenerative disease of the lumbar spine and to formulate treatment recommendations based on this review. In March 2003, this group was convened. Invitations were extended to approximately 12 orthopedic and neurosurgical spine surgeons active in the Joint Section or in the North American Spine Society to ensure participation of nonneurosurgical spine surgeons. The recommendations that were developed represent the product of the work of the group, with input from the Guidelines Committee of the American Association of Neurological Surgeons/CNS and the Clinical Guidelines Committee of North American Spine Society.

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Grades of Recommendation

Standards Recommendations of the strongest type, based on Class I evidence reflecting a high degree of clinical certainty

Guidelines Recommendations based on Class II evidence reflecting a moderate degree of clinical certainty

Options Recommendations based on Class III evidence reflecting unclear clinical certainty

COST ANALYSIS

Lumbar fusion may be associated with a high short-term cost, especially if instrumentation is placed; however, there appear to be long-term economic benefits associated with lumbar fusion including resumption of employment. To describe the economic impact of lumbar fusion for degenerative disease adequately, it is important to define the patient population treated with fusion and to compare efficacy as well as the costs of other treatment alternatives. Any such analysis should include both short- and long-term costs and benefits.

See "Part 3: assessment of economic outcome" in the "Availability of Companions Documents" field for the complete analysis.

METHOD OF GUIDELINE VALIDATION

External Peer Review
Internal Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The committee presents data that have been reviewed by the major organizations representing neurological surgery and orthopedic surgery. The Board of Directors of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) Executive Committee have reviewed these Lumbar Fusion Guidelines and formally voted their approval. In addition, input and approval was received and greatly appreciated from the AANS/CNS Guidelines committee.

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

The grades of recommendations (standards, guidelines, and options) and classes of evidence (I–III) are defined at the end of the "Major Recommendations" field.

Standards. There is insufficient evidence to recommend a treatment standard.

Guidelines. There is insufficient evidence to recommend a treatment guideline.

Options. 1) Lumbar spinal fusion is not recommended as routine treatment following primary disc excision in patients with a herniated lumbar disc causing radiculopathy. 2) Lumbar spinal fusion is recommended as a potential surgical adjunct in patients with a herniated disc in whom there is evidence of preoperative lumbar spinal deformity or instability. 3) Lumbar spinal fusion is recommended as a potential surgical adjunct in patients with significant chronic axial low-back pain associated with radiculopathy due to a herniated lumbar disc. 4) Reoperative discectomy is recommended as a treatment option in patients with a recurrent lumbar disc herniation. 5) Reoperative discectomy combined with fusion is recommended as a treatment option in patients with a recurrent disc herniation associated with lumbar instability, deformity, or chronic axial low-back pain.

Summary

There is no convincing medical evidence to support the routine use of lumbar fusion at the time of a primary lumbar disc excision. There is conflicting Class III medical evidence regarding the potential benefit of the addition of fusion in this circumstance. Therefore, the definite increase in cost and complications associated with the use of fusion are not justified. Patients with preoperative lumbar instability may benefit from fusion at the time of lumbar discectomy; however, the incidence of such instability appears to be very low (<5%) in the general lumbar disc herniation population. Patients who suffer from chronic low-back pain, or are heavy laborers or athletes with axial low-back pain, in addition to radicular symptoms may also be candidates for fusion at the time of lumbar disc excision. Patients with a recurrent disc herniation have been treated successfully with both reoperative discectomy and reoperative discectomy combined with fusion. In patients with a recurrent lumbar disc herniation with associated spinal deformity, instability, or associated chronic low-back pain, consideration of fusion in addition to reoperative discectomy is recommended.

Definitions:

Grades of Recommendation

Standards Recommendations of the strongest type, based on Class I evidence reflecting a high degree of clinical certainty

Guidelines Recommendations based on Class II evidence reflecting a moderate degree of clinical certainty

Options Recommendations based on Class III evidence reflecting unclear clinical certainty

Classes of Evidence

Class I Evidence from one or more well-designed, randomized controlled clinical trials, including overviews of such trials

Class II Evidence from one or more well-designed comparative clinical studies, such as nonrandomized cohort studies, case-control studies, and other comparable studies, including less well-designed randomized controlled trials

Class III Evidence from case series, comparative studies with historical controls, case reports, and expert opinion as well as significantly flawed randomized controlled trials

CLINICAL ALGORITHM(S)

None provided

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").

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

Appropriate use of lumbar fusion in patients with disc herniation and radiculopathy

POTENTIAL HARMS

Lumbar fusion following discectomy is associated with increased operative time, blood loss, hospital stay, complication rates, and overall treatment cost.

QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

The strength of an evidence-based document is only as strong as the foundation on which it is built. This comprehensive document chronicles the state of scientific information in 2005. Many of the published reviews presented flawed results due to poorly defined outcome measures, inadequate numbers of patients, and comparison of dissimilar treatment groups. These studies of "apples and oranges" gleaned little scientific information; therefore, for the purpose of this review, the authors have discarded Class III studies whenever stronger scientific evidence was available. The result is that most of the published studies on lumbar fusion were not included on this document. When Class I or II scientific evidence was available, standards and guidelines were formulated; however, in most cases, the scientific data were only adequate to support recommendations for treatment options. The aforementioned results do not detract from the importance of this document; rather, the need for the neurosurgical community to design and complete prospective randomized controlled studies to answer the many lingering clinical questions with rigorous scientific power can clearly be seen. As more data continue to be accumulated, revisions of this document will be needed.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Getting Better
Living with Illness

IOM DOMAIN

Effectiveness

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2005 Jun

GUIDELINE DEVELOPER(S)

American Association of Neurological Surgeons - Medical Specialty Society
Congress of Neurological Surgeons - Professional Association

SOURCE(S) OF FUNDING

This project was funded entirely by a grant from AANS/CNS Section on Disorders of the Spine. No funding was received from any commercial entity to support the production or publication of these guidelines.

GUIDELINE COMMITTEE

Guidelines Committee of the American Association of Neurological Surgeons/Congress of Neurological Surgeons (CNS)

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Primary Authors: Daniel K. Resnick, MD; Tanvir F. Choudhri, MD; Andrew T. Dailey, MD; Michael W. Groff, MD; Larry Khoo, MD; Paul G. Matz, MD; Praveen Mummaneni, MD; William C. Watters III, MD; Jeffery Wang, MD; Beverly C. Walters, MD, MPH; Mark N. Hadley, MD

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

ENDORSER(S)

North American Spine Society - Medical Specialty Society

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves Web site.

Print copies: Available from Daniel K. Resnick, M.D., Department of Neurological Surgery, University of Wisconsin Medical School, K4/834 Clinical Science Center, 600 Highland Avenue, Madison, Wisconsin 53792; Email: Resnick@neurosurg.wisc.edu.

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from Daniel K. Resnick, M.D., Department of Neurological Surgery, University of Wisconsin Medical School, K4/834 Clinical Science Center, 600 Highland Avenue, Madison, Wisconsin 53792; Email: Resnick@neurosurg.wisc.edu.

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on January 5, 2007. The information was verified by the guideline developer on January 29, 2007.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

NGC DISCLAIMER

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