In most orthopedic departments, there’s a big chance spinal fusions are one of the most common procedures, and also one of the most costly and lucrative.
The surgery can be great for people who suffer traumatic injuries, such as from car crashes, or who have congenital disorders or even arthritis in the back with some slippage of vertebrae in the spine.
But the procedure is also potentially one of the most overused and unnecessary, and surgeons often recommend it for a host of conditions despite unclear evidence of its effectiveness.
The lack of rigorous clinical trial evidence is apparent in a recent study, which raises questions about why surgeons are cutting into so many backs without clearly knowing whether it works, and about a healthcare industry that relies on expensive medical devices that don’t undergo the same stringent regulatory reviews as prescription drugs.
For hospital administrators, expensive procedures and devices used by doctors may seem par for the course in the U.S. healthcare system. But the rising frequency and cost of spinal fusions suggest a closer look at orthopedic departments may be needed. Spinal fusions can, on average, cost between $60,000 to $110,000.
Read more: Reducing spinal fusions in the real world
A British Medical Journal review of randomized controlled clinical trials on several elective orthopedic surgeries found little evidence to support spinal fusions on patients with degenerative disk disease. There was also little evidence to justify surgery over nonoperative treatments for five other orthopedic procedures, including rotator cuff repairs.
And spinal fusion, even beyond the one indication the study looked at, is controversial. There’s hazy evidence, at best, that it should be used to treat a condition called spinal stenosis, which is a severe form of arthritis that mainly affects older people.
In the absence of trial data on the effectiveness of spinal fusions for many conditions, and of the medical devices used in the procedure, surgeons are left to rely on sales pitches from self-interested devicemakers—often the same companies that have financial relationships with those physicians—as well as observational data that is not as robust.
Surgical treatment usually has two components: decompression and spinal fusion. For the former, physicians open patients’ backs and cut out arthritic bone that pinches the nerves that run from the back to the leg. For the latter, surgeons use a bone graft to weld vertebrae together, often with a medical device to stabilize the area.
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“That procedure is probably way overused and studies say that in patients who have spinal stenosis itself, it’s more expensive and riskier, with more complications. And researchers have shown that despite decompression alone being safer and with similar outcomes, fusion is increasing” said Dr. Steven Atlas, an associate professor of medicine at Harvard Medical School.
Spinal fusions are risky, in part because patients can wind up with worse problems than when they started. That’s especially concerning for patients with conditions for which the surgery may not even be advisable.
“Over time, fusion—where you’re fusing two bones together and there’s no movement between the bones and there used to be movement—there’s evidence that you increase arthritic changes above and below where the fusion was,” Atlas said. That can increase stress at the segments below and above the vertebrae, leading to a domino effect in which patients need more fusions to alleviate pain.
But despite the available evidence, spinal fusions have proliferated over time.
Lumbar spine fusions increased by 142% between 1998 and 2008, according to a study by the Spine Research Foundation. A review of Medicare claims shows that a more complicated version of the surgery involving more surfaces of the vertebrae, increased 38% from 2004 to 2007, indicating a shift toward more complex and costly operations. By 2015, more than 40% of spinal fusions performed in the U.S. were for indications with less evidence of clinical appropriateness.
“In the absence of there being some plague that has caused spines to start dissolving—the spines of aging people are not much different than they were in last 50 to 60 years. The gross increase in reported pathology and reported necessity of involved surgeries, it’s not a smoking gun, but certainly something smells rotten, that’s for sure,” said Dr. Eugene Carragee, a professor of orthopedic surgery at the Stanford University School of Medicine and former chief of the spinal surgery division.
And for indications that are commonly thought to benefit from the procedure, a recent New England Journal of Medicine study of spinal surgeries in Norway found that patients who underwent less costly decompressions alone experienced equivalent pain relief as patients who also had spinal fusion surgery.
The British Medical Journal’s meta-analysis relies entirely on randomized controlled clinical trials, the gold standard in research. But the absence of other forms of information, such as observational studies and real-world case studies, is a limitation. The article also doesn’t account for surgeons’ experience and medical judgment.
Physicians aren’t casually doing surgeries they know to be useless. But they aren’t necessarily considering the clinical evidence when deciding what to recommend, and they aren’t likely to have any encounters with the patients years into the recovery period, except in cases of complications. So they may not really understand what is and isn’t effective.
“They get up in the morning and think, ‘What can I do best for my patients? I don’t need (randomized controlled trials). I’ve seen the benefits in my patients, and they get better,” said Jonathan Skinner, a professor at the Dartmouth Institute who studies the relationship between innovations and healthcare cost growth.
“But once the surgery is done, the surgeon doesn’t see the patient anymore unless there’s a problem,” Skinner said. “It’s hard for any surgeon to evaluate, and there’s a sort of a bias toward thinking about the successes and ignoring the non-successes.”
The benefit of randomized controlled trials is they provide hard evidence about whether a medical intervention works, what complications are possible and how to account for the placebo effect. This kind of research offers the best possible evidence to allow clinicians and patients to make risk-benefit calculations.
“If, on average, this thing doesn’t work, the burden is on you to tell me why for this particular patient, it’s going to work, beyond just a faith-based argument,” said Dr. Vikas Saini, president of the Lown Institute, a nonpartisan think tank and research organization that focuses on unnecessary care and other healthcare issues. “Some skepticism is warranted, not enough to shut down those surgeries, but enough to say, let’s be careful.”
Spinal fusions do, indeed, carry risks. Spinal fusions for stenosis and other conditions not backed by strong evidence of effectiveness are associated with poor outcomes, according to research the Lown Institute in collaboration with Australian academics published this year. Out of seven low-value procedures, inpatient spinal fusions were affiliated the most with hospital-acquired conditions, adverse patient safety indicators and unplanned hospital admissions after outpatient procedures, their review of Medicare claims from 2016 to 2018 found.