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## Complete Summary

#### GUIDELINE TITLE

Guidelines for the performance of fusion procedures for degenerative
disease of the lumbar spine. Part 4: radiographic assessment of fusion.

#### 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 4: radiographic assessment of fusion. J Neurosurg
Spine 2005 Jun;2(6):653-7. \[21 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16028732)

#### 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

#### GUIDELINE CATEGORY

Diagnosis\
Technology Assessment

#### CLINICAL SPECIALTY

Internal Medicine\
Neurological Surgery\
Neurology\
Orthopedic Surgery\
Physical Medicine and Rehabilitation\
Radiology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To examine the literature regarding the ability of various diagnostic
techniques to assess fusion status after lumbar fusion is performed to
treat degenerative disease

#### TARGET POPULATION

Patients with degenerative disease of the lumbar spine treated with
lumbar fusion

#### INTERVENTIONS AND PRACTICES CONSIDERED

Radiographic assessment of fusion status using combination of
noninvasive modalities such as static plain radiography, lateral
flexion-extension radiography, and computerized tomography (CT)

**Note**: The following radiographic tests were considered but not
recommended due either to unreliability of the tests or lack of
scientific evidence: static lumbar radiography as a stand-alone test,
technetium-99 bone scanning, Roentgen stereophotogrammetric analysis
(RSA), polytomography, magnetic resonance imaging, and ultrasonography.

#### MAJOR OUTCOMES CONSIDERED

Accuracy, sensitivity, specificity, and positive and negative predictive
value of radiographic studies

### 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 between 1966 and July 2003 was conducted using the search terms
\"lumbar spine fusion assessment,\" \"lumbar spine pseudoarthrosis,\" or
\"lumbar spine fusion outcome.\" The search was restricted to references
in the English language involving humans. This yielded a total of 1076
references. The titles and abstracts of each of these references were
reviewed. Only papers concerned with the assessment of fusion status
following arthrodesis procedures for degenerative lumbar disease were
included. Additional articles were obtained from the bibliographies of
the selected articles. Forty-five references were identified that
provided either direct or supporting evidence relevant to the
radiographic assessment of lumbar fusion status. Reports involving Class
III or better medical evidence are listed in Table 1 in the original
guideline document. Supportive data are provided by additional
references listed in the bibliography of the original guideline.

#### NUMBER OF SOURCE DOCUMENTS

7 reports involving Class III or better medical evidence are listed in
Table 1 in 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***. Static lumbar radiographs are not recommended as a
stand-alone means to assess fusion status following lumbar arthrodesis
surgery.

***Guidelines***. 1) Lateral flexion and extension radiography is
recommended as an adjunct to determine the presence of lumbar fusion
postoperatively. The lack of motion between vertebrae, in the absence of
rigid instrumentation, is highly suggestive of successful fusion. 2)
Technetium- 99 bone scanning is not recommended as a means to assess
lumbar fusion.

***Options***. Several radiographic techniques, including static
radiography, lateral flexion--extension radiography, and/or computed
tomography (CT) scanning, often in combination, are recommended as
assessment modality options for the noninvasive evaluation of
symptomatic patients in whom failed lumbar fusion is suspected.

**Summary**

The assessment of fusion status with static plain radiography is
accurate in approximately two thirds of patients treated with lumbar
fusion when the radiographic results are compared with surgical
exploration findings. Therefore, static plain radiography is not
recommended as a stand-alone modality following lumbar fusion
procedures. The addition of lateral flexion--extension radiography may
improve accuracy because the lack of motion between fused lumbar
segments on lateral views is highly suggestive of a solid fusion. Some
degree of motion between segments may be present even when the spine has
fused. The amount of motion allowable across fused segments is not
clear, and the role of internal fixation in limiting motion has also not
been adequately addressed. The addition of multiplanar CT scanning
results in the detection of pseudarthrosis in some patients in whom
fusion has been deemed successful based on plain radiographic criteria.
Therefore, CT scanning may be more accurate in the determination of
fusion status than plain radiography; however, a rigorous comparison of
modern CT scanning and surgical exploration has not been performed. It
appears that Roentgen stereophotogrammetric analysis (RSA) is
exquisitely sensitive for the detection of motion between vertebral
bodies, and the loss of motion between treated vertebral segments does
appear to indicate the presence of fusion. The modality, however, is
invasive and not widely available. Furthermore, the only comparison of
RSA with surgical exploration provided only Class III medical evidence
supporting the accuracy of RSA. It is recommended that multiple
modalities be used for the noninvasive evaluation of symptomatic
patients with suspected fusion failure because no radiographic gold
standard exists.

**[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

Use of appropriate radiographic modalities for assessment of fusion
status following lumbar fusion for degenerative disease of the lumbar
spine

#### POTENTIAL HARMS

-   Plain static radiography can render false-positive or false-negative
    results and is not recommended as a stand-alone test.

-   The radiographic assessment of lumbar fusion status is imperfect,
    consumes healthcare resources, and exposes the patient to ionizing
    radiation.

### 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)

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 4: radiographic assessment of fusion. J Neurosurg
Spine 2005 Jun;2(6):653-7. \[21 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16028732)

#### 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/04 - Radiographic Assessment of Fusion.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).

-   Guidelines for the performance of fusion procedures for degenerative
    disease of the lumbar spine. Part 5: correlation between
    radiographic and functional outcome. 2005 Jun. 4 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/05 - Corellation Between Radiographic and Functional Outcome.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>.

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on January 4, 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

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008