A patient recently reported to her Regenexx doctor that she had spoken to people at a clinic called “North American Spine” and had been told that there was zero percent chance of her getting worse after a minimally invasive surgical procedure. That the clinic refused to allow this patient to speak directly to a doctor raises a red flag, but of far more concern is the common-sense fact that there’s no medical procedure ever devised by man that has a zero percent rate of causing a complication or worsening the initial problem.
So who the heck is North American Spine and why would they tell an intelligent professional woman that there is no chance of her getting worse? A few seconds searching on Google indicates the following:
There is no doctor available with whom the patient could speak, because this “clinic” is a marketing group of businessmen formed to sell procedures, collect the money, and then assign an unrelated doctor to do the procedure.
The claim that there is a zero percent chance of worsening has been disputed in multiple lawsuits against the company and its doctors. Patients have claimed that they not only got worse, but more significantly, that they have suffered paralysis and bowel and bladder problems. A paper on the company website that reports on a case series of patients who had the company’s Accurascope procedure backs this up. The paper reported just under a 30 percent complication rate. This included new nerve symptoms down the leg and foot drop that took a patient six months from which to recover. In addition, one patient developed a serious infection (meningitis) and three patients had other infections.
The procedure uses a scope to insert a catheter that can cut out or Laser out a disc bulge. The Korean research about this technique published on the company’s website looks at case studies of 109 patients. The conclusion of the research is inconsistent with the marketing on the front of the website, which touts an 82 percent “success rate.” The Korean paper shows that around two years after the procedure, 32 percent of patients rated their post-operative condition as “excellent,” 24 percent as “good,” 26 percent as “fair,” and 18 percent as “poor.” The marketing business guys didn’t report this as a physician would, that based on this data 58 percent (32 percent “excellent” plus 26 percent “good”) had a successful outcome. Instead they added in the 26 percent of patients who reported their condition as “fair” to get to 82 percent.
If we look at patient-reported pain data from the Korean paper, this falls into line with the procedure success data. Pain before the procedure was 7.6 out of 10 and then 3.6 out of 10 after the surgery. That’s on average about a 50 percent improvement in pain.
So much for zero percent worsening and complications! The Korean paper on the company website shows that many patients experienced complications. It also shows that the results on the website were over-rated compared to the results found in the research paper listed on the site. More importantly the story told by the business guys trying to sell procedures to patients isn’t consistent with the medical reality described in the research.
Patients should beware of any medical procedure that claims to have a zero percent complications and a zero percent chance of worsening their condition.
Patients also should beware of any clinic that doesn’t allow them to know which doctor will be performing their procedure, only that the doctor will be “board-certified.” That board certification may have little to do with the medical procedure the patient is seeking to undergo, and knowing the doctor and his or her experience level with the procedure is critical. This would extend to finding out about prior lawsuits against the doctor and against the clinic.
“North American Spine Review: 0% Chance of Worsening—Really Guys” first appeared as a post on the Regenexx blog.