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Expense, frequency, efficacy of spine surgery debated
Better diagnostics, greater patient expectations and an aging population may be affecting the number of procedures performed.
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Orthopedic spine surgeons recently have had to address the clinical and socioeconomic issues surrounding spine surgery and fusion procedures as a result of articles published in the New England Journal of Medicine and The New York Times.
Questions have been raised about the number of spine surgeries being performed, the indications for surgery, and how patient sophistication and expectation levels are affecting these numbers. Some have estimated that this number could reach 250,000 cases in the United States this year.
Orthopedics Today spoke with spine surgeons and researchers about some of these issues. They agreed that the costs associated with spine surgery are escalating. “Enormous amounts of money are involved. That’s the issue that was brought up in the original New York Times article, and I don’t think it can be ignored that the amount of money [being spent] is really astronomical if there are so many hundreds of thousands of operations being done,” said Eugene Carragee, MD, professor of orthopedic surgery, Stanford University School of Medicine.
A study conducted by researchers at Duke University found that people in the United States with back pain had total individual and incremental health care expenditures that reached nearly $117 billion in 1998.
“Back pain is a costly disease,” said the study’s lead researcher Xuemei Luo, PhD. Medicare recently spent $750 million on spine fusions in a single year, according to one New York Times article.
The attention called to the costly problem of back pain and the evidence that medical science does not have complete answers to the problem are good, David F. Fardon, MD, told Orthopedics Today. “Such observations call for more expenditure of resources to find effective preventives and treatment.” Fardon, of Knoxville, Tenn., is a member of the spine section of the Orthopedics Today Editorial Board.
The cost of technology
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Technological advancement in spine surgery is contributing, some contend, to the increased cost and frequency of spine surgery. An increasing number of hospitals and physicians promote that they can provide the latest implants and treatments. Manufacturers market new and better devices and fusion aids.
“We have the latest technology and produce the most medical advances in the world, but this costs money and increases the cost of care as we develop more new treatments,” said Scott D. Boden, MD, at the Emory Spine Center in Atlanta and section editor of Orthopedics Today Spine Section.
But, there is no direct evidence that technology alone is driving up the number of spine procedures, he said. “It is a likely combination of several factors: better diagnostics, increased patient awareness, increased patient expectations and the aging population.”
Richard A. Deyo, MD, MPH, professor of medicine and health services at the University of Washington, Seattle, said a study he and his colleagues conducted about lumbar surgery procedures found that the rate in the United States is about double the rate in other developed countries such as Western Europe, Australia, New Zealand and Canada.
European investigators are perhaps more critical of fusions and other spine surgery, since most randomized trials comparing fusion with and without instrumentation have come from Europe, he said. “They’ve been scrutinizing the issue a bit more carefully than we have, and certainly their overall surgical rate suggests that they’re more selective than we are about on whom and when they operate,” Deyo said.
Carragee said: “The controversy really centers around fusion for common backache, not fusion for tumors, infection, fractures, unstable spines or deformities of scoliosis and polio, the long litany of major spinal diseases. The indications for surgery in subsets of those are not terribly controversial, but they account for something like only 25% of the fusions being done. The 75% of the fusions are being done for regular degenerative back changes.”
“The problem is that just because the frequency of fusion operations is higher in one location it doesn’t mean the higher number is wrong,” Boden said. “We don’t know what the right frequency should be.”
Deyo and others argued that very point in a commentary published in NEJM. Spine fusion for degenerative discs and indications for which its use is unclear based on the literature — such as herniated discs — may be unwarranted, they wrote.
According to Boden: “For a degenerative spondylolisthesis with symptomatic stenosis, the literature suggests these patients do better long term if also fused. The biggest controversy surrounds fusions for discogenic low back pain (LBP) from degenerative discs or annular tears.”
More accurate diagnoses that clearly match a patient with a given indication to the most appropriate treatment could help. Boden, who chairs the National Spine Network (NSN), a consortium dedicated to improving the quality of spine care, said the NSN is “focusing on developing ways to more easily collect patient outcomes so that people can track which treatments benefit which patients.”
Awaiting more results
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Among its projects, the NSN is conducting an 11-center randomized clinical trial of LBP patients with herniated discs, spinal stenosis and degenerative spondylolisthesis. In the Spine Patient Outcomes Research Trial (SPORT), patients will be randomized to undergo surgical and nonsurgical treatment. There will be an observational cohort of nonrandomized patients in each arm of the trial who receive the same interventions and follow-up, but who self-select their treatment. At least 2000 patients are expected to participate.
Spondylolisthesis patients in the SPORT trial’s treatment arm will be randomized to undergo fusions. Those results should reveal important information, Deyo said.
Better definitions of success may be required to more accurately gauge outcomes of a given treatment. “I think the definition of success is part of the problem,” Carragee said.
For example, the success rankings used in some Food and Drug Administration trials for new spine devices were very low, such as a two-point decrease in the pain score and 10% to 15% increases in the functional score, he said. “These are really minimal changes.”
As a result, an 80% success rate is now considered good in some cases, Carragee said. “That’s not at all what the patients have in mind. … In general, most people expect to have pain that’s really minimal postoperatively. They’re expecting to have a high degree of function. They expect to be working, and they don’t expect to be taking narcotics, but those goals are very rarely met.”
In a 30-patient study Carragee recently conducted concerning expectations for spinal fusion, 15% to 25% of patients met those goals. But using FDA criteria, “80% of our people met their goals or were successes by a drop in their pain score and an increase in their functional scores. But, they’re really pretty minor improvements.”
Better imaging has undoubtedly contributed to more accurate diagnoses. “The diagnosis is made more easily with better imaging and the surgery to help [the condition] is more refined,” Boden said. MRI provides “much better visualization than plain radiographs. On the other hand, the challenge is to separate findings that are part of normal aging from those that are causing symptoms.”
Often MRI findings are incidental to rather than explanatory of symptoms, Fardon said. “Correlation of MRI findings with the clinical syndrome is an important challenge to the judgment of skilled clinicians but does not negate the importance of positive and negative imaging observations.”
The usefulness of MRI data depends largely upon appropriate selection of patients and interpretation of results, but it helps with confirming negative or nonconcordant findings, directing a prescribed exercise program or administering injection treatments, he said.
Timing of an intervention or deciding which one is most appropriate may be further complicated by the fact that when something abnormal is seen on an MRI, it is difficult to determine whether that is the cause of the patient’s symptoms, Deyo said. Several studies have been conducted using MRI to image the spines of asymptomatic or “normal” patients only to reveal abnormal findings. “That complicates the decision making.”
Fortunately, the vast majority of back pain incidents in a given year are resolved without medical care. “Weight reduction, exercise, healthy habits and patience with minor pain are more important than medical care for most cases of nonspecific LBP,” Fardon said.
“For those who ignore or fail in spite of such measures, nonoperative medical care of LBP is important. … It is for a very small subset of the population of patients with LBP who have failed nonoperative care and have a surgically correctable problem that surgery is a consideration.”
In those cases where pain persists, even after surgery, often it comes down to putting up with the pain, which is “easy to say but very hard to do,” Fardon said.
Dr. Boden is a paid consultant for Medtronic Sofamor Danek.