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## Complete Summary

#### GUIDELINE TITLE

Guidelines for the performance of fusion procedures for degenerative
disease of the lumbar spine. Part 11: interbody techniques for lumbar
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 11: interbody techniques for lumbar fusion. J
Neurosurg Spine 2005 Jun;2(6):692-9. \[37 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16028739)

#### 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

Assessment of Therapeutic Effectiveness\
Management\
Technology Assessment

#### CLINICAL SPECIALTY

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

#### INTENDED USERS

Health Plans\
Managed Care Organizations\
Physicians

#### GUIDELINE OBJECTIVE(S)

To examine the literature reporting experience with interbody fusion
techniques and their relative safety and efficacy compared with
posterolateral fusion techniques for the treatment of patients with
low-back pain

#### TARGET POPULATION

Patients with low-back pain due to degenerative disease of the lumbar
spine

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Posterolateral fusion (PLF)

2.  Interbody fusion (anterior lumbar interbody fusion \[ALIF\],
    posterior LIF \[PLIF\], and transformal LIF \[TLIF\])

**Note**: See \"Major Recommendations\" for specific indications for
each technique.

#### MAJOR OUTCOMES CONSIDERED

-   Effectiveness of interbody fusion techniques in terms of back and
    leg pain relief, fusion rate, length of hospital stay, reoperation
    rate, return to work, and patient satisfaction

-   Safety of interbody fusion techniques in terms of complication rates

### 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 National Library of Medicine database of
the literature published from 1966 to June 2003 was performed. A search
using the subject heading \"spinal fusion, lumbar, treatment outcome,
low-back pain\" yielded 1030 citations. Clinical series reported in
English-language journals dealing with adult patients who had undergone
fusion with instrumentation for degenerative lumbar disease were
selected (333 references). Relevant articles pertaining to the
comparison of interbody fusion techniques with other surgical techniques
or nonsurgically treated controls were selected and are summarized in
the evidentiary table in the original guideline document. A number of
case series provide supporting data and are referenced in the
bibliography of the original guideline.

#### NUMBER OF SOURCE DOCUMENTS

17 articles pertaining to the comparison of interbody fusion techniques
with other surgical techniques or nonsurgically treated controls were
selected.

#### 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***. In the context of a single-level stand-alone anterior
lumbar interbody fusion (ALIF) or ALIF with posterior instrumentation,
the addition of a posterolareral fusion (PLF) is not recommended as it
increases operating room time and blood loss without influencing the
likelihood of fusion or the functional outcome.

***Options***. 1) It is recommended that both PLF and interbody fusion
(posterolateral lumbar interbody fusion \[PLIF\], transformal LIF
\[TLIF\], or ALIF) techniques be considered as treatment options for
patients with low-back pain due to degenerative disc disease (DDD) at
one or two levels. 2) Placement of an interbody graft is recommended as
a treatment option to improve fusion rates and functional outcome in
patients undergoing surgery for low-back pain due to DDD at one or two
levels. The surgeon is cautioned that the marginal improvement in fusion
rates and functional outcome with these techniques is associated with
increased complication rates, particularly when combined approaches
(that is, 360 degrees) are used. 3) The use of multiple approaches
(anterior and posterior) to accomplish lumbar fusion is not recommended
as a routine option for the treatment of patients with low-back pain
without deformity.

**Summary**

The majority of reviewed medical evidence suggests that interbody
techniques are associated with higher fusion rates compared with PLF
when applied to patients with low-back pain due to DDD limited to one or
two levels. The evidence is generally of poor quality and retrospective
in nature. Conflicting evidence exists supporting the role of interbody
graft placement for improvement of functional outcomes; however, there
is no Class I or II evidence to suggest that the use of an interbody
graft is associated with worse outcomes, and Class II evidence exists to
suggest that outcomes are improved. Complication rates of interbody
graft placement, particularly of circumferential procedures, are higher
in most series. Many complications, however, are associated with pedicle
screw fixation and not with interbody graft placement per se. In the
context of a single-level stand-alone ALIF or ALIF with posterior
instrumentation, there does not appear to be a substantial benefit to
the addition of a PLF. The addition of a PLF to a construct that already
includes an interbody graft is, however, associated with increased costs
and complications. Therefore, although the addition of supplemental
fixation (a 270 degree fusion) may be necessary for biomechanical
reasons, it may not be appropriate to subject the patient to the
morbidity of a full posterior exposure for placement of graft material.

Significant differences in clinical outcomes between the various
interbody techniques have not been convincingly demonstrated. No general
recommendation can therefore be made regarding the technique that should
be used to achieve interbody fusion.

**[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 interbody techniques for lumbar fusion in patients
with degenerative disease of the lumbar spine

#### POTENTIAL HARMS

-   Complication rates of interbody graft placement, particularly of
    circumferential procedures, are higher compared with posterolateral
    fusion (PLF) in most series. Complications include: reoperations for
    instrumentation removal, donor site pain, pressure sores, and screw
    malposition. Many complications, however, are associated with
    pedicle screw fixation and not with interbody graft placement per
    se.

-   The addition of PLF to a construct that already includes an
    interbody graft is associated with increased costs and
    complications.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   Significant differences in clinical outcomes between the various
    interbody techniques have not been convincingly demonstrated. No
    general recommendation can therefore be made regarding the technique
    that should be used to achieve interbody fusion.

-   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 11: interbody techniques for lumbar fusion. J
Neurosurg Spine 2005 Jun;2(6):692-9. \[37 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16028739)

#### 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/11 - Interbody Techniques for Lumbar 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).

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

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008