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Draft Key Questions:
These questions were available for public comment from Jan. 24–Feb. 21, 2012

Spinal Fusion for Treating Painful Lumbar Degenerated Discs or Joints

Draft Key Questions

Question 1
For adults with low back pain attributed to degenerative disc disease of the lumbar spine, does spinal fusion differ from nonoperative treatment in the ability to improve:
  1. Patient-centered outcomes such as function, quality of life, or pain?
  2. Adverse events?
Question 2
For adults with low back pain attributed to degenerative (not congenital) stenosis of the lumbar spine, does spinal fusion differ from nonoperative treatment in the ability to improve:
  1. Patient-centered outcomes such as function, quality of life, or pain?
  2. Adverse events?
Question 3
For adults with low back pain attributed to degenerative spondylolisthesis of the lumbar spine, does spinal fusion differ from nonoperative treatment in the ability to improve:
  1. Patient-centered outcomes such as function, quality of life, or pain?
  2. Adverse events?
Question 4
For adults with low back pain attributed to degenerative disc disease of the lumbar spine, does spinal fusion differ from other spinal procedures (e.g., total disc replacement, disc decompression) in the ability to improve:
  1. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?
  2. Patient-centered outcomes such as function, quality of life, or pain?
  3. Adverse events?
Question 5
For adults with low back pain attributed to degenerative stenosis of the lumbar spine, does spinal fusion differ from other spinal procedures (e.g., decompressive laminectomy and minimally invasive procedures, including those using devices) in the ability to improve:
  1. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?
  2. Patient-centered outcomes such as function, quality of life, or pain?
  3. Adverse events?
Question 6
For adults with low back pain attributed to spondylolisthesis of the lumbar spine, does spinal fusion differ from other spinal procedures (e.g., repair, vertebrectomy) in the ability to improve:
  1. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?
  2. Patient-centered outcomes such as function, quality of life, or pain?
  3. Adverse events?
Question 7
For adults with low back pain attributed to degenerative disc disease of the lumbar spine, do spinal fusion approaches (e.g., anterior, posterior, combined) and techniques (e.g., instrumentation or graft material) differ in the ability to improve:
  1. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?
  2. Patient-centered outcomes such as function, quality of life, or pain?
  3. Adverse events?
Question 8
For adults with low back pain attributed to degenerative stenosis of the lumbar spine, do spinal fusion approaches (e.g., anterior, posterior, combined) and techniques (e.g., instrumentation or graft material) differ in the ability to improve:
  1. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?
  2. Patient-centered outcomes such as function, quality of life, or pain?
  3. Adverse events?
Question 9
For adults with low back pain attributed to spondylolisthesis of the lumbar spine, do spinal fusion approaches (e.g., anterior, posterior, combined) and techniques (e.g., instrumentation or graft material) differ in the ability to improve:
  1. Perioperative outcomes such as surgery time, blood loss, or length of hospital stay?
  2. Patient-centered outcomes such as function, quality of life, or pain?
  3. Adverse events?
Question 10
Are there patient characteristics (e.g., pain severity, prior treatment) that are associated with better or worse outcomes after spinal fusion?
  1. Patient-centered outcomes such as function, quality of life, or pain
  2. Adverse events

Figure 1. Draft analytic framework for spinal fusion for painful lumbar degenerative disc or joint disease

Figure 1 is an analytic framework that depicts the events that adults undergoing treatment for degenerative disc disease or degenerative joint disease of the lumbar spine may experience. The framework includes from left to right the patient population of interest, intervention of interest (spinal fusion) and comparator treatments, intermediate outcomes, final health outcomes, and adverse effects that may occur from treatment.  In the first frame, we have our patient population of interest, “adults with lumbar degenerative disc disease or degenerative joint disease.” Degenerative joint disease includes stenosis and spondylolisthesis. An arrow leads the patient to either the treatment of interest (spinal fusion) or a comparator. The comparator treatments are listed vertically. The first is “non-operative treatments,” which will be covered under Key Questions 1 to 3. Listed below is the next comparator treatment, “other surgery,” which will be discussed under Key Questions 4 to 6. Lastly, we list the final comparator, “other lumbar fusion,” addressed in Key Questions 7 to 9. Next, the path leads to the third and fourth frames, which represent the outcomes of interest. In the third frame we list peri-operative outcomes “surgery time,” “blood loss,” and “duration of hospital stay.” Peri-operative outcomes will be discussed for all key questions except Key Questions 1 to 3, which compare surgery to non-operative treatments. Peri-operative outcomes are connected by a dashed line to “Patient-Centered Outcomes” in the fourth frame. These outcomes include “function”, “quality of life”, and “pain,” and address treatment efficacy. In addition, an arrow connects all treatments to adverse treatment effects.

Abbreviations: KQ = key question

Background

Most adults in the United States will experience low back pain during their lives.1 Based on data from the National Ambulatory Medical Care Survey, there were an estimated 42.4 million primary physician visits for low back pain in 2003–2004.2 Data from the National Health Interview Survey were used to estimate that 17 percent, or 34 million adults, experienced low back pain lasting a whole day or longer during a 3-month study period in 2002.3 Fortunately, an estimated 80 to 90 percent of people with acute low back pain experience complete resolution within 6 weeks, and only 5 to 10 percent develop chronic pain, although recurrences may occur.1 In about 85 percent of patients, the cause of low back pain is never identified.4

Degeneration of discs and bones in the lower back can cause chronic low back pain. While degenerative lumbar diseases do not always cause symptoms, they can cause severe chronic low back pain due to vertebral instability and abnormal biomechanics and/or compression on other anatomical sites including nerves. Such conditions may occur in isolation or in combination and include:

  • Degenerative disc disease: Degeneration of intervertebral discs, thought to be genetically influenced and due to mechanical loading associated with ageing or trauma.5,6 Degenerative disc disease may include “real or apparent desiccation, fibrosis, narrowing of the disk space, diffuse bulging of the annulus beyond the disc space, extensive fissuring (i.e., numerous annular tears) and mucinous degeneration of the annulus, defects and sclerosis of the endplates, and osteophytes at the vertebral apophyses.”6
  • Stenosis: Narrowing of the spinal canal to <10 mm in diameter, sometimes associated with intervertebral disc herniation or degeneration, or narrowing of nerve root canals or intervertebral foramina, which can cause nerve root compression.4,6,7 Degeneration can be due to infection, trauma, or surgery. Only degenerative causes of stenosis will be addressed in this report.
  • Spondylolisthesis: Change in position of vertebrae relative to other vertebrae (sometimes called a “slip,”), which can be due to degeneration of apophyseal joints or facet arthropathy.6,8 Underlying degenerative causes may include arthritis of facet joints, ligament malfunction, and/or insufficient muscle stabilization.9 Only degenerative causes of spondylolisthesis will be addressed in this report.

The National Health Interview Survey found the prevalence of back pain in general is higher among Americans aged 45 years and older, women, people with lower levels of education, and Native Americans and Alaskans.3,10 Sixty-nine percent of low back pain visits were for adults aged 25 to 64 years.2 Prevalence of degenerative disc disease is greatest among people 40 years old,11 and prevalence of herniated disks are highest among people 35 to 45 years old.4 Spondylolisthesis most commonly occurs in people aged at least 408 to 50 years.9 Most people over age 60 have radiographic evidence of spinal stenosis,7 and most people with signs and symptoms are over age 70 years.4 General risk factors for degenerative spinal disease include age at least 50 years, female, pregnancies, African heritage, joint laxity, and anatomic predisposition.9

Patients with low back pain and a “red flag” symptom or sign require immediate evaluation and may require prompt surgical treatment. Red flags include pain due to trauma; sudden or unexplained loss or change in bowel or bladder control or urinary retention; sudden or unexplained saddle anesthesia or bilateral leg weakness; signs and symptoms suggestive of cancer or spinal infection.12 These patients are outside the scope of this review.

Although there is more than one degenerative cause of low back pain, nonsurgical treatments are generally the same. Treatments, beginning with the most conservative, include: bed rest (<2 days); nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen; antispasmodics; opioids; cardiovascular exercise; physical therapy; facet or epidural steroid injections; complementary and alternative medicine; chiropractic care; and cognitive behavioral therapy.4,7-9,13-16 External braces may also be prescribed for spondylolisthesis or stenosis.7,8

Information on appropriate selection of patients with degenerative spine disease for lumbar fusion in evidence-based clinical practice guidelines is limited. The most frequently stated indication for spinal surgery in general for degenerative lumbar disease is unsatisfactory response to nonsurgical treatment efforts lasting at least 3 to 6 months. Additional surgical indications for spinal stenosis include claudication, neurologic deficit, and myelopathy.7 Additional surgical indications for spondylolisthesis include neurogenic claudication, progressive neurologic deficit, and bladder and/or bowel symptoms.9 The most common conditions treated by spinal surgery are intervertebral disc herniations and degenerative spondylolisthesis with stenosis.17 Indications specifically for fusion surgery for spondylolisthesis may include failure of conservative treatments, symptom progression, at least 50 percent slippage, and skeletal immaturity.4

Spinal fusion (also known as spinal arthrodesis) is an inpatient surgical procedure intended to permanently immobilize the functional spinal unit (two adjacent vertebrae and the disk between them), limiting painful movement.4 Most fusions today are performed by using instrumentation such as pedicle and facet screws, rods, and cages18 and incorporate a combination of graft material made of a patient’s own bone (autograft), donor bone (allograft), or a synthetic substance such as recombinant human bone morphogenetic protein to promote fusion. Surgeons may initiate the procedure through the peritoneum or retroperitoneum (anterior approach), the back (posterior approach), or a combination of sites (anteroposterior approach). Different surgical techniques include14:

  • Posterolateral fusion (PLF): Dorsal surgery that joins vertebrae by their transverse processes
  • Posterior lumbar interbody fusion (PLIF): Dorsal surgery that joins vertebrae by their bodies
  • Transforaminal lumbar interbody fusion (TLIF): A form of PLIF that joins vertebrae on one side only
  • Anterior lumbar interbody fusion (ALIF): Anterior surgery that can be performed by open transperitoneal (through the peritoneum) or, more commonly, retroperitoneal (from behind the abdominal cavity), mini-open, or laparoscopic techniques
  • Circumferential fusion: 360° fusion that joins vertebrae by their entire bodies and transverse processes, typically performed by combining ALIF and PLF

The main potential advantage of lumbar fusion is to provide pain relief and restore quality of life and function when less extensive and invasive treatments cannot. However, it poses potential harms ranging from anesthesia risks and surgical complications to need for subsequent reoperation for later complications.19

  • Upon reviewing a 2006 technology assessment on the use of lumbar fusion surgery to treat chronic low back pain due to degenerative disc disease in older adults,19 clinicians on a Medicare Evidence Development and Coverage Advisory Committee lacked confidence in published evidence of pain relief efficacy and safety, and found its informativeness for patient selection unclear.20 Identified studies had inconsistent findings regarding efficacy when compared to nonsurgical treatment, enrolled heterogeneous patient populations, and had design and execution limitations.

More recent systematic reviews of randomized controlled trials comparing lumbar fusion to nonsurgical care21,22 and comparing different lumbar fusion strategies22 have not permitted firm conclusions either, also citing limitations in the published evidence. Confounding factors preventing firm conclusions included differences in patient populations entering the different studies, as well as different treatments and methodological limitations. Likely due to space limitations in peer-reviewed journal articles, few details about enrolled patients and no details about the nonsurgical strategies were reported. Safety was not assessed in these reviews. A systematic review on adverse events found substantial differences in rates of nonunion, reoperation, neurologic complications, and dural injury and that the differences in nonunion rates were associated with source of trial funding.23 Older patients with comorbidities may be more likely to suffer adverse events after fusion for degenerative lumbar disease.24 Our searches did not identify a single review that addresses the effectiveness and safety of lumbar fusion compared to nonsurgical treatment, other surgeries and of different fusion techniques and instrumentations.

A systematic review on the comparative effectiveness and safety of lumbar fusion for low back pain attributed to degenerative disease of the lumbar spine will help inform clinical decisionmaking, including best treatment selection for patients with different degenerative conditions and demographic characteristics. The findings of this review should address the information needs of various parties, including clinicians and patients considering treatment options, professional societies interested in issuing position statements or guidelines, value analysis groups and purchasing groups in hospitals making purchasing decisions, and third-party payers constructing or updating coverage policies or responding to appeals.

PICOTS:

Population(s)
  • Adults with low back pain attributed to lumbar degenerative disc disease or degenerative joint disease (e.g., stenosis, spondylolisthesis). Patients must have both low back pain and a diagnosis of degenerative disc disease, stenosis, or spondylolisthesis diagnosed as causing the low back pain. Ideally, studies will report diagnostic criteria. We recognize diagnostic criteria may vary by clinician and will explore whether diagnostic criteria are associated with differences in outcome if data allow. Patient characteristics such as race/ethnicity, duration of symptoms, presence or absence of radicular pain, occupational status, and presence of comorbid conditions will be evaluated as subgroups or investigated for association with outcomes where data allow.
Interventions
  • Spinal fusion. Any clinically relevant method of performing spinal fusion—both the surgical approach and the instrumentation used—will be included. Abandoned methods (those no longer being used) will not be reviewed. The Technical Expert Panel will be consulted to identify which methods have been abandoned. Differences in treatment (e.g., hardware, surgical approach) will be investigated for association with outcome where data allow.
Comparators
  •  Only direct comparisons will be considered. Indirect comparisons and historically controlled trials will not be reviewed due to high risk of bias.
  • KQs 1–3: Nonoperative treatments. Any nonoperative treatment or combination of nonoperative treatments will be considered (e.g., bed rest, NSAIDs or acetaminophen, antispasmodics, opioids, cardiovascular exercise, physical therapy, facet or epidural steroid injections, complementary and alternative medicine, chiropractic care, cognitive behavioral therapy).
  • KQs 4–6: Alternative spinal surgeries (e.g., total disc replacement, discectomy, surgical decompression).
  • KQs 7–9: Direct comparison of different spinal fusion surgeries (e.g., approaches, techniques).
Outcomes
  • Perioperative outcomes (KQs 4–9)
  1. Surgery time
  2. Blood loss
  3. Duration of hospital stay
  • Patient-centered outcomes (short- and long-term effectiveness)
  1. Function (e.g., Oswestry Disability Index)
  2. Quality of life (e.g., Short Form [36] Health Survey)
  3. Pain (e.g., visual analogue scales or numerical rating scales)
  • Adverse effects of intervention(s)

    Any harms reported in the literature including, but not limited to, nonunion, reoperation, neurologic injury, blood clots, and infection
Timing
  • Perioperative: up to 2 weeks postsurgery (KQs 4–9)
  • Short term: 2 weeks to 6 months
  • Intermediate term: 6 months to 4 years
  • Long term: longer than 4 years
Setting
  • We will include all settings

Definition of Terms

  • ALIF: anterior lumbar interbody fusion
  • NSAIDs: nonsteroidal anti-inflammatory drugs
  • PLE: posterolateral fusion
  • PLIF: posterior lumbar interbody fusion

Cited References

  1. Manchikanti L. Epidemiology of low back pain. Pain Physician 2000 Apr;3(2):167-92. PMID: 16906196.
  2. Licciardone JC. The epidemiology and medical management of low back pain during ambulatory medical care visits in the United States. Osteopath Med Prim Care 2008 Nov;2:11. PMID: 19025636.
  3. Strine TW, Hootman JM. US national prevalence and correlates of low back and neck pain among adults. Arthritis Rheum 2007 May 15;57(4):656-65. PMID: 17471542.
  4. Hu SS, Tribus CB, Tay BK, et al. Chapter 5: Disorders, diseases, and injuries of the spine. In: Skinner HB, ed. CURRENT diagnosis and treatment in orthopedics. 4th ed. The Ne York: McGraw-Hill Companies, Inc.; 2006. p. 221-97.  
  5. Vernon-Roberts B, Moore RJ, Fraser RD. The natural history of age-related disc degeneration: the pathology and sequelae of tears. Spine (Phila Pa 1976) 2007 Dec 1;32(25):2797-804. PMID: 18246000.
  6. Modic MT, Ross JS. Lumbar degenerative disk disease. Radiology 2007 Oct;245(1):43-61. PMID: 17885180.
  7. Hsiang JK. Spinal stenosis. In: Medscape Reference: Physical Medicine and Rehabilitation Articles: Lumbar Spine Disorders. Available at: http://emedicine.medscape.com/rehabilitation Exit Disclaimer. Accessed July 7, 2011.
  8. Froese BB. Lumbar spondylolysis and spondylolisthesis. In: Medscape Reference: Physical Medicine and Rehabilitation Articles: Lumbar Spine Disorders. Available at: http://emedicine.medscape.com/rehabilitation Exit Disclaimer. Accessed July 7, 2011.
  9. Kalichman L, Hunter DJ. Diagnosis and conservative management of degenerative lumbar spondylolisthesis. Eur Spine J 2008 Mar;17(3):327-35. PMID: 18026865.
  10. Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: estimates from U.S. national surveys, 2002. Spine (Phila Pa 1976) 2006 Nov 1;31(23):2724-7. PMID: 17077742.
  11. Patel RK, Slipman CW. Lumbar degenerative disk disease. In: Medscape Reference: Physical Medicine and Rehabilitation Articles: Lumbar Spine Disorders. Available at: http://emedicine.medscape.com/rehabilitation Exit Disclaimer. Accessed July 7, 2011.
  12. Institute for Clinical Systems Improvement. Adult low back pain. Bloomington, MN: Institute for Clinical Systems Improvement; 2010.
  13. Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med 2007 Oct 2;147(7):478-91. PMID: 17909209.
  14. Resnick DK. Spinal fusion for discogenic back pain: patient selection, operative techniques, and outcomes. Tech Neurosurg 2003;8(3):176-90.
  15. North American Spine Society. Diagnosis and treatment of degenerative lumbar spondylolisthesis. Burr Ridge, IL: North American Spine Society; 2008.
  16. North American Spine Society. Diagnosis and treatment of degenerative lumbar spinal stenosis. Burr Ridge, IL: North American Spine Society; 2007.
  17. Cummins J, Lurie JD, Tosteson TD, et al. Descriptive epidemiology and prior healthcare utilization of patients in the Spine Patient Outcomes Research Trial's (SPORT) three observational cohorts: disc herniation, spinal stenosis, and degenerative spondylolisthesis. Spine (Phila Pa 1976) 2006;31(7):806-14. PMID: 16582855.
  18. Maghout Juratli S, Franklin GM, Mirza SK, et al. Lumbar fusion outcomes in Washington State workers' compensation. Spine (Phila Pa 1976) 2006 Nov 1;31(23):2715-23. PMID: 17077741.
  19. McCrory DC, Turner DA, Patwardhan MB, et al. Spinal Fusion for Treatment of Degenerative Disease Affecting the Lumbar Spine. Technology Assessment (Draft Prepared by Duke Evidence-based Practice Center). Rockville, MD: Agency for Healthcare Research and Quality; November 2006.
  20. Schafer J, O'Connor D, Feinglass S, et al. Medicare Evidence Development and Coverage Advisory Committee Meeting on lumbar fusion surgery for treatment of chronic back pain from degenerative disc disease. Spine (Phila Pa 1976) 2007 Oct 15;32(22):2403-4. PMID: 18090077.
  21. Carreon LY, Glassman SD, Howard J. Fusion and nonsurgical treatment for symptomatic lumbar degenerative disease: a systematic review of Oswestry Disability Index and MOS Short Form-36 outcomes. Spine J 2008 Sep-Oct;8(5):747-55. PMID: 18037354.
  22. Mirza SK, Deyo RA. Systematic review of randomized trials comparing lumbar fusion surgery to nonoperative care for treatment of chronic back pain. Spine (Phila Pa 1976) 2007 Apr 1;32(7):816-23. PMID: 17414918.
  23. Fenton JJ, Mirza SK, Lahad A, et al. Variation in reported safety of lumbar interbody fusion: influence of industrial sponsorship and other study characteristics. Spine (Phila Pa 1976) 2007 Feb 15;32(4):471-80. PMID: 17304140.
  24. Jo DJ, Jun JK, Kim KT, et al. Lumbar interbody fusion outcomes in degenerative lumbar disease: comparison of results between patients over and under 65 years of age. J Korean Neurosurg Soc 2010 Nov;48(5):412-8. PMID: 21286477.

Additional References

Systematic Reviews

Andrade RS, Groth S. New diagnostic techniques: endobronchial ultrasound-guided needle aspiration and electromagnetic navigation. Minerva Pneumol 2009 Sep;48(3):261-70.

Gibson JN, Waddell G. Surgery for degenerative lumbar spondylosis. Cochrane Database Syst Rev 2005 Oct 19;(4):CD001352. PMID: 16235281.

Han X, Zhu Y, Cui C, et al. A meta-analysis of circumferential fusion versus instrumented posterolateral fusion in the lumbar spine. Spine (Phila Pa 1976) 2009 Aug 1;34(17):E618-25. PMID: 19644321.

Kovacs FM, Urrutia G, Alarcon JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine (Phila Pa 1976)  2011 Sep 15;36(20):E1335-51. PMID: 21311394.

Martin CR, Gruszczynski AT, Braunsfurth HA, et al. The surgical management of degenerative lumbar spondylolisthesis: a systematic review. Spine (Phila Pa 1976) 2007 Jul 15;32(16):1791-8. PMID: 17632401.

van den Eerenbeemt KD, Ostelo RW, van Royen BJ, et al. Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature. Eur Spine J 2010 Aug;19(8):1262-80. PMID: 20508954.

Wang MY, Cummock MD, Yu Y, et al. An analysis of the differences in the acute hospitalization charges following minimally invasive versus open posterior lumbar interbody fusion. J Neurosurg Spine 2010 Jun;12(6):694-9. PMID: 20515357.

Wu RH, Fraser JF, Hartl R. Minimal access versus open transforaminal lumbar interbody fusion: meta-analysis of fusion rates. Spine (Phila Pa 1976) 2010 Dec 15;35(26):2273-81. PMID: 20581757.

Additional Guideline in National Guideline Clearinghouse

National Guideline Clearinghouse Web site. Guideline summary: low back disorders. (Prepared by the ECRI Institute.) Rockville, MD: Agency for Healthcare Research and Quality; May 2006. Last Updated April 2011. Available at: http://www.guideline.gov/content.aspx?id=12540&search=low+back+disorders. Accessed January 23, 2012.

Assessment Methodology

Lilford R, Braunholtz D, Harris J, et al. Trials in surgery. Br J Surg 2004 Jan;91(1):6-16. PMID: 14716788.

Resnick DK. Evidence-based spine surgery. Spine (Phila Pa 1976) 2007 May 15;32(11 Suppl):S15-9. PMID: 17495580.