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## Complete Summary

#### GUIDELINE TITLE

Guidelines for the performance of fusion procedures for degenerative
disease of the lumbar spine. Part 9: fusion in patients with stenosis
and spondylolisthesis.

#### BIBLIOGRAPHIC SOURCE(S)

Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, Mummaneni
P, Watters WC 3rd, Wang J, Walters BC, Hadley MN, American Association
of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines
for the performance of fusion procedures for degenerative disease of the
lumbar spine. Part 9: fusion in patients with stenosis and
spondylolisthesis. J Neurosurg Spine 2005 Jun;2(6):679-85. \[34
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16028737)

#### 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: stenosis and spondylolisthesis

#### 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 literature concerning the role of fusion after
decompression surgery in patients with degenerative spondylolisthesis
and stenosis

#### TARGET POPULATION

Patients with stenosis and spondylolisthesis

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Lumbar posterolateral fusion (PLF) in addition to decompression

2.  Pedicle screw fixation as an adjunct to lumbar fusion

#### MAJOR OUTCOMES CONSIDERED

Effectiveness of treatment in terms of pain relief, walking tolerance,
functional improvement, medication usage, activities of daily living,
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 August 2003 was conducted using the search terms
\"fusion and degenerative spondylolisthesis.\" The search was restricted
to the English language and yielded 217 references. The titles and
abstracts of each of these references were reviewed, and papers not
concerned with the use of fusion with degenerative spondylolisthesis
were discarded. Eighty-five references were identified that provided
either direct or supporting evidence relevant to the use of fusion for
degenerative lumbar spondylolisthesis. These papers were reviewed, and
relevant references from the bibliographies were identified. All papers
providing Class III or better medical evidence are summarized in Table 1
of the original guideline document. Additional supportive data are
provided in references listed in the bibliography of the original
guideline.

#### NUMBER OF SOURCE DOCUMENTS

32 papers providing Class III or better medical 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

***Note from the National Guideline Clearinghouse (NGC) and the Congress
of Neurological Surgeons***: An addendum has been released for this
guideline. See the [AANS/CNS Joint Section on Disorders of the Spine and
Peripheral Nerves Web
site](http://www.spinesection.org/files/pdfs/fusion_guidelines/09a - Addendum for Guideline 9.doc)
for details.

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

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

***Options***. 1) The performance of a lumbar posterolateral fusion
(PLF) is recommended for patients with lumbar stenosis and associated
degenerative spondylolisthesis who require decompression. 2) Pedicle
screw fixation as an adjunct to lumbar posterolateral fusion should be
considered as a treatment option in patients with lumbar stenosis and
spondylolisthesis in cases in which there is preoperative evidence of
spinal instability or kyphosis at the level of the spondylolisthesis or
when iatrogenic instability is anticipated.

**Summary**

The best medical evidence available in the literature confirms the
utility of fusion for improving patient outcomes following decompression
for stenosis associated with spondylolisthesis. The majority of evidence
from other studies comparing outcomes after decompression alone or
decompression combined with PLF in patients with stenosis and
spondylolisthesis also favors the performance of PLF. The medical
evidence regarding the use of pedicle screw fixation in this patient
population is rated as Class III and is inconsistent. A consistent
benefit associated with the use of pedicle screw fixation has been
reported in patients with preoperative instability or kyphosis.
Iatrogenic instability following decompression is associated with poor
outcomes and may also be treated with PLF involving supplemental
instrumentation. The precise definition of instability or kyphosis has
varied among researchers and requires further study.

**[Definitions]{.underline}**:

**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 posterolateral fusion (PLF) and pedicle screw
fixation in patients with stenosis and spondylolisthesis

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   The precise definition of instability or kyphosis has varied among
    researchers and requires further study.

-   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)

Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, Mummaneni
P, Watters WC 3rd, Wang J, Walters BC, Hadley MN, American Association
of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines
for the performance of fusion procedures for degenerative disease of the
lumbar spine. Part 9: fusion in patients with stenosis and
spondylolisthesis. J Neurosurg Spine 2005 Jun;2(6):679-85. \[34
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16028737)

#### 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](http://www.spinesection.org/files/pdfs/fusion_guidelines/09 - Fusion in Patients with Stenosis and Spondylolisthesis.pdf).

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:

-   Introduction to the guidelines for the performance of fusion
    procedures for degenerative disease of the lumbar spine. 2005 Jun.
    1 p. Available in Portable Document Format (PDF) from the [AANS/CNS
    Joint Section on Disorders of the Spine and Peripheral Nerves Web
    site](http://www.spinesection.org/files/pdfs/fusion_guidelines/00 - Introduction - Dr Robert Heary.pdf).

-   Guidelines for the performance of fusion procedures for degenerative
    disease of the lumbar spine. Part 1: introduction and methodology.
    2005 Jun. 2 p. Available in Portable Document Format (PDF) from the
    [AANS/CNS Joint Section on Disorders of the Spine and Peripheral
    Nerves Web
    site](http://www.spinesection.org/files/pdfs/fusion_guidelines/01 - Introduction and Methodology.pdf).

-   Guidelines for the performance of fusion procedures for degenerative
    disease of the lumbar spine. Part 3: assessment of economic outcome.
    2005 Jun. 6 p. Available in Portable Document Format (PDF) from the
    [AANS/CNS Joint Section on Disorders of the Spine and Peripheral
    Nerves Web
    site](http://www.spinesection.org/files/pdfs/fusion_guidelines/03 - Assessment of Economic Outcome.pdf).

-   Addendum for Guideline #9. Electronic copies: Available from the
    [AANS/CNS Joint Section on Disorders of the Spine and Peripheral
    Nerves Web
    site](http://www.spinesection.org/files/pdfs/fusion_guidelines/09a - Addendum for Guideline 9.doc).

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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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008