Like most conscientious physicians, we try our best to practice “evidence-based medicine.” As spine surgeons, that isn’t always easy to do, given the beating operations such as spinal fusion have received in the press.
Let us tell you about Anne Williams, a patient of ours who has given us permission to describe her story. An administrator at a community college in Hickory, N.C., Anne developed severe back and leg pain at age 60. Here’s what she had to say about it:
“The pain got so bad that I ended up sleeping on the floor of my bedroom for eight months. Lying in bed was too painful. When I had to walk, which I tried to avoid at all costs, the pain in my back and legs made me bend over and lean on a walking stick. The grocery store was about the only place I went outside of work, because I could lean over the shopping cart.”
An MRI showed stenosis — the arthritic narrowing of Anne’s spinal canal. It also showed that one of the bones (vertebra) in her spine was slipping on top of another. She tried everything: physical therapy, steroid injections into her spinal canal, and pain medications. Nothing worked. Months later, desperate and nearly defeated, she thought about surgery. We recommended removing bone and ligament that were clamping down on her nerves. To do it the right way, screws and rods would have to be used to stop the abnormal movements of her “slipped” vertebrae. In other words, a spinal fusion.
Here’s where the issue of evidence comes to the fore.
The effectiveness of surgical procedures for back pain, especially spinal fusion, has come under fire in the media. A systematic review of spinal fusion, published in 2007, was interpreted by New York Times reporter Gina Kolata as concluding that the procedure is “no better than alternative treatments.” There has been a quiet campaign among medical experts over the past few years to rein in the use of the procedure.
But let’s take a close look at that evidence. The 2007 review included just four trials of spinal fusion. In one trial, fusion was superior to conservative options like exercise or talk therapy. Two of the other trials weren’t large enough to detect a difference in pain between the fusion and non-fusion groups. The fourth was plagued with poor follow-up, making it difficult to interpret the results. That’s not exactly a resounding dismissal of spinal fusion. You wouldn’t know that, though, from Kolata’s recent New York Times story headlined “Why ‘Useless’ Surgery Is Still Popular.”
How spine surgeons think
Different medical problems pose different diagnostic and treatment challenges. If you develop appendicitis with a ruptured appendix, the diagnosis and treatment are as clear as the task facing a firefighter standing in front of a burning house.
Spinal disease is different. It’s more like taking your car to a mechanic for a clanking sound. The mechanic must pop the hood, examine various parts of the engine and exhaust, and run some tests. Sometimes it’s easy to tell what’s causing the noise and a simple tune-up will fix it. Other times there’s more testing involved, and the car may have to stay in the shop for days as the mechanic tries different solutions.
In a similar spirit, spine surgeons see patients with symptoms such as back pain and leg pain. This puts into motion an investigation designed to establish where the pain is coming from and why it is occurring. Only then is it possible to create a rational treatment plan. As a general rule, surgeons don’t see patients with low back pain and immediately think, “Let me do a spinal fusion.” Instead, they map out treatment options that range from less invasive to more invasive over time.
And here is the crux of the matter: Non-surgical treatments simply don’t do the job for patients like Anne Williams.
“My first night at home [after the surgery] I slept in my own bed. You have no idea how wonderful that felt. And the pain in my back and legs went away. It’s been almost a year since the surgery and I stand straight, pain-free. I’ll always be grateful for my surgery and rehab.”
In clinical practice, we don’t put conservative options and spinal fusions into a cage match as soon as a diagnosis is made, as was done in the randomized trials mentioned earlier. Instead, treatments are offered one after the other, ideally starting with the least invasive option, like exercise therapy. The goal is to find the best therapy for the individual. This raises a question for opponents of spinal fusion: Do they expect individuals who have not gotten relief from conservative treatments to continue them ad nauseam because some experts have described spinal fusion as “next to useless,” as the Times did?
The question of whether spinal fusion improves all back pain, at its onset, is somewhat meaningless. Back pain is a broad symptom, not a diagnosis. The real question is whether spinal fusion helps people with specific diagnoses once conservative options fail. The evidence for that is encouraging.
The Spine Patient Outcomes Research Trial (SPORT), published in 2007 (but not included in the systematic review mentioned earlier) demonstrated that surgery, including fusion, was better than “usual care” (active physical therapy, education about exercising at home, and the use of nonsteroidal anti-inflammatory agents) for patients with spinal narrowing and slipped vertebrae. In another randomized trial published this year, fusion surgery improved overall health-related quality of life better than non-fusion surgery among patients with minor slippage of their vertebrae.
Looking at how well surgery works in large groups of patients may actually become outdated. In this new age of precision medicine and personalized health care, what matters most is not whether a group of patients with a particular diagnosis did better, on average, when offered a treatment like spinal fusion. What truly matters is whether a specific patient who hasn’t been helped by conservative treatments, with his or her unique blend of risk factors and goals, would stand to benefit from spinal fusion and be satisfied with the result.
Clinical “big data” registries, which record the details and outcomes of real-world care, can pave the way for patient-centered and personalized care. Two studies based on a large-scale national registry covering 26 US states show remarkable improvements in quality of life for patients undergoing low-back fusions after getting little relief from conservative treatments.
To be sure, an alarming fraction of American health care is unnecessary — upwards of $850 billion spent each year has been deemed “waste.” Spine surgeons clearly need to be mindful of overutilization and focus on delivering high-value therapies. However, sweeping condemnations in the media run the risk of scaring away patients from therapies that have real value when applied to the right person, at the right time, in the right way.
Anne Williams is an example of the value of this approach.
Ahilan Sivaganesan, MD, is a clinical research and spine fellow at Vanderbilt University. Matthew McGirt, MD, is a neurosurgeon in Charlotte, N.C. Andrew Sumich, MD, is a physical medicine and rehabilitation physician in Charlotte, N.C. Clinton Devin, MD, is an orthopedic spine surgeon in Nashville, Tenn. (Sivaganesan reports no conflicts of interest; McGirt is a consultant for Stryker; Sumich is on a study advisory board for Mesoblast; Devin is a consultant for Pacira, a defense expert witness, and has a research grant from the Lumbar Spine Research Society. McGirt, Sumach, and Devin have all received payments from various orthopedic device manufacturers.)