Surgical fusion hardware is one of the most successful medical business plans ever devised. You take a screw and rods made for a few dollars in China or India and sell them for thousands of dollars. As a result, we’ve gone from a world where implanting hardware in the spines of patients was rare, to one where it’s now the standard. In fact, in 2017, it’s hard to find spine surgeons who are willing to operate without implanting fusion hardware. Despite this, the research shows that the hardware doesn’t add any benefit but does add significant risk. Now a new study again shows that for the most severe low-back patients with spinal stenosis and slipped vertebrae, adding in hardware does nothing but enrich hardware manufacturers and surgeons.
What Is a Fusion?
A fusion is where parts of the spine are bolted together. To do this, the surgeon usually implants hardware in the form of screws and rods and sometimes spacers between the discs. Fusions rates when I was in residency in the ’90s were very low, but now, for some diagnoses in some communities, they are approaching 100%.
Are There Some Patients Who Really Need a Fusion?
Yes, but they are few and very far between. Out of the last approximately 1,000 patients I’ve seen who have had a fusion, I would estimate that 10–20 really needed the procedure because there was no other way their problem could be managed. Half of those patients had been in severe traumas where their spines were severed and needed to be put back together
My Patient Yesterday
It’s hard sometimes to write and manage a daily blog. I’m often asked how I can keep it up with everything else I have to do. It all comes down to what my mother would call “piss and vinegar.” Meaning, writing about what I’m passionate about based on what I see in the clinic helps me on those days where I’d rather take a few days off. This morning is one of those days, when looking at a patient’s neck made it 100% certain that there would be a blog this morning.
This patient had a long history of neck pain and fusion at C3–C4 in the ’90s. Those screws eventually began to back out, and the hardware was suspected of infection, so he recently underwent a C3–T1 fusion. Basically, the surgeon fused almost his whole neck from both the back and front. He now has what I call a “Grand Canyon” scar in the back of his neck. Basically, a large valley of lost tissue carved where critical neck muscles used to live. This is there because to get a device in that big requires extensive tissue damage. As I stared at this gap of tissue, I asked myself, with multiple studies showing that fusion adds nothing but side effects to spine surgery, how did we get here?
How Did We Get Here?
We got here because fusion is an amazing business plan. First, as a manufacturer of these devices, you can take a screw made for a few dollars in China and mark it up to $1,000 or more. Those types of markups exist nowhere else in manufacturing and make the $600 toilet seat military contracting debacle of the ’80s look cheap. During that LA Times investigation that caused heads in the Pentagon to roll, a screw cost a mere $37.
Second, the insurance reimbursement for spinal fusion is much better than a routine disc or bone-spur-removal surgery. Basically, the surgeon, when considering professional and surgery-center fees, can earn 2–3 times the amount when a fusion is performed. Meaning, there is a huge financial disincentive to avoid a fusion and just remove the bone spurs or bulging discs pressing on the nerves.
What’s bizarre is that the rule used to be that a one-level fusion was sometimes needed, a two-level should be rare, and a three-level was not smart. Somewhere over the last decade, that changed to what I call the maxi-fusion that my patient received. These devices are now huge, so much so that implanting them causes maximum tissue damage. They now span 4,5, 6, or more spinal levels. If a one-level fusion was a hand grenade when it came to tissue destruction, these things are the hydrogen bombs of spine surgery.
Does Fusion Work?
The research over the last few years has not shown good things for fusion. Here’s a list of studies showing it is ineffective:
- For a patient with low-back stenosis (arthritis pressing on nerves), low-back fusion was no more effective than a typical decompression surgery that just removes the arthritic bone spurs pressing on the nerves.
- For the same type of stenosis patients, low-back fusion was no more successful than physical therapy in this randomized controlled trial.
- Ten–fifteen years after a fusion, on average, patients reported the same pain that they had prior to the surgery.
- Low-back fusion was again no better than physical therapy in this study.
I always tell my patients that fusion is a dog with fleas. One of those fleas is ASD, or adjacent segment disease. See my video below for more info on ASD:
These studies demonstrate the side effects and complications associated with fusion:
- Adding a fusion increases the side effects by 60–90%.
- The number of patients who need a second fusion increases with time.
- Fusion causes hip-replacement prostheses to wear out faster.
How Is Fusion Sold?
My patient yesterday was sold a fusion in the same way I have seen it sold to hundreds to thousands of patients. If you don’t have this surgery, you will be paralyzed. Is this true? Not really. One of the trials above showed that several years after the surgery, patients who were randomized to physical therapy were the same as those who got the fusion surgery.
The New Research
The new research is Swiss, and patients with spinal stenosis with degenerative spondylolisthesis (one vertebra slipped forward of the other) had either decompression surgery or decompression plus fusion. Like other studies, this one again demonstrated that there was no advantage to adding the fusion.
The upshot? Why are we still doing this to patients? My patient yesterday is literally “screwed.” He’s still in severe pain and believes that he has somehow been saved from the wheelchair, but the data really doesn’t bear out that this would have been likely. In the meantime, what I can do for “maxi-fusion” patients is less than what I could have done if the fusion had never happened or if they had a one-level fusion. Despite my continued review of the literature showing that fusions don’t help most patients, the business plan of the $1,000 screw will keep churning. 🙁