Health technology reviews

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Lumbar fusion for degenerative disc disease

Lumbar fusion was initially reviewed by the HTA program in 2008

  • In 2009, an update literature search was conducted to determine if newly available published evidence could change the original coverage determination. The topic was not selected for re-review.
  • In 2014, the HCA director selected lumbar fusion for re-review based on newly available published evidence that could change the original determination.
  • A re-review of lumbar fusion was conducted in 2015.

Status: Decision completed.

View findings and decision

Policy context

Due to the prevalence of low back pain and the varying nature of the conditions that underlie it, numerous management options are available.  These options vary substantially in their intensity, degree of invasiveness, and most importantly, level of evidence regarding their effectiveness.  Although there is lack of consensus on when lumbar fusion surgery is indicated, how the surgery should be performed, and long-term prognosis after surgery (Christensen, 2004), the number of lumbar fusion surgeries performed in the U.S. has nevertheless increased more than two-fold between 2000 and 2009 (Yoshihara, 2014).  In particular, some studies have shown poor success rates for lumbar fusion when used to treat low back pain caused by disk degeneration alone (Herkowitz, 1995).  There is significant interest on the part of patients, clinicians, policymakers and other stakeholders in evaluating the clinical and economic impact of lumbar fusion for patients with chronic low back pain and degenerative disc disease (DDD).

Primary criteria ranking

  • Safety = High
  • Efficacy = High
  • Cost = High

Assessment timeline (2015)

  • Draft key questions published: May 6, 2015
  • Public comment period: May 6 to May 20, 2015
  • Final key questions published: June 3, 2015
  • Draft report published: August 18, 2015
  • Public comment period: August 18 to September 17, 2015
  • Final report published: October 16, 2015
  • HTCC public meeting: November 20, 2015

Background

Low back pain is an exceedingly common complaint, with a lifetime prevalence ranging from 60-70% (WHO, 2013). Chronic low back pain may be seen in as many as one-quarter of patients six months after an initial episode (Johannes, 2010). The economic impact of low back pain is also substantial. It is the second most common reason for all physician visits in the U.S. (Licciardone, 2008), and is responsible for approximately $30 billion in direct medical costs annually, of which $18.3 billion is related to ambulatory care (Soni, 2010). In addition, low back pain is a major cause of lost productivity; it is estimated that over 3% of the U.S. work force is compensated for back pain or injury each year (Stewart, 2003), with approximately 187 million missed work days and wage losses accounting for an additional $22.4 billion in indirect costs (AAOS, 2009).

Low back pain can be caused by various specific and nonspecific conditions, which differ in prevalence and affect different age groups. Degenerative disc disease (DDD) is a common condition associated with low back pain in many individuals. Use of the term “disease” to describe this condition is something of a misnomer, however, as disc degeneration (dehydration and shrinkage) is a natural consequence of aging, and many individuals never develop overt symptoms of DDD. Diagnosis and subsequent treatment typically involves an initial history and physical examination by a clinician. Depending on the presentation, the clinician might prescribe various self-care therapies or will perform a diagnostic exam to check the patient’s pain tolerance, functional capabilities, and reflexes (Pengel, 2003). An MRI and/or CT scan may be used to identify other potential causes of the patient’s symptoms, including other co-occurring conditions such as radiculopathy (compression of the root nerve), spondylolisthesis (displacement of the vertebral disc), or spinal stenosis (narrowing of the spinal canal) (Ullrich, 2013).

Multiple treatment options are available for symptoms associated with DDD of the lower back, including so-called “conservative” measures such as physical and exercise therapy, spinal manipulation, alternative therapies (e.g., acupuncture), and medication; minimally-invasive treatments such as spinal injections and radiofrequency ablation; and surgical intervention. Lumbar fusion surgery, which involves the creation of a permanent connection across the vertebral space by means of a graft, is often considered when conservative treatments fail to relieve the patient’s back and/or leg pain (Eck, 2014). However, many patients may be at risk of persistent low back pain, as initial surgery is subject to high rates of reoperation with declining success rates after each consecutive surgery. It is estimated that as many as 80,000 cases of so-called “failed back surgery syndrome” are seen in the U.S. each year (Ragab, 2008).

Due to the prevalence of low back pain and the varying nature of the conditions that underlie it, numerous management options are available. These options vary substantially in their intensity, degree of invasiveness, and most importantly, level of evidence regarding their effectiveness in the diverse subpopulations of patients with low back pain. Although there is lack of consensus on when lumbar fusion surgery is indicated, how the surgery should be performed, and long-term prognosis after surgery (Christensen, 2004), the number of lumbar fusion surgeries performed in the U.S. has nevertheless increased more than two-fold between 2000 and 2009 (Yoshihara, 2014). In particular, some studies have shown poor success rates for lumbar fusion when used to treat low back pain caused by disk degeneration alone (Herkowitz, 1995). Not surprisingly, there is significant interest on the part of patients, clinicians, policymakers, and other stakeholders in evaluating the clinical and economic impact of lumbar fusion for patients with chronic low back pain and DDD.