Our Review Summary
This major network broadcast–-about a surgical procedure that is purported to quickly relieve pain in hundreds of thousands of people with common low back pain–is devoid of evidence and sound reporting. Among the questions it fails to answer:
- Is there any evidence suggesting that fusion is an effective treatment for chronic low back pain? If so, in whom?
- What does the research say about pain relief and improvement in disability after the procedure? What does it say about the length of hospital stay and return to activity?
- Is FDA approval of minimally invasive surgery based on a device application? If so, were the results durable over a long period of time? Was it compared to “usual” treatment (e.g. standard fusion)?
- What do randomized trials say about the comparative effectiveness of fusion versus nonsurgical programs that combine graded exercise and cognitive therapy? (Answer: results of fusion and nonsurgical care are often the same. See “Treatment Options” below.)
- What is the cost of this procedure (likely more than $50,000)? What are the costs of alternative treatments that are just as effective (e.g. graduated exercise and cognitive therapy)?
- Are there no serious potential harms other than colon perforation associated with the new procedure? What about pulmonary embolism, cardiac arrest, stroke, nerve damage and other complications historically associated with fusion? Is exposure to “more than 200 x-rays” harmless because it is purportedly less radiation than a CT scan? Are there no surgical failures? (About 1 in 5 fusions fail.)
- Are there no experts to provide a balanced discussion of this procedure and its nonsurgical alternatives?
There are a number of high-quality studies and commentaries on spinal fusion. Reporters have an obligation to their readers and viewers to become familiar with them. Here is just one recent excerpt (November 15, 2008) of the type of commentary available. A search of randomized trials comparing treatments or observational studies about complications will quickly turn up others. It is the reporter’s job to find reliable sources who can accurately represent the clinical evidence.
“The term invasiveness in surgery is frequently misused in clinical medicine. Often minimally invasive surgery suggests to the patient that the surgical intervention is minimized in comparison to a standard procedure. Recently, orthopedic surgeons have begun to replace the hip joint but are confusing minimally invasive with minimal access surgery. Although there may be increasing evidence that hospitalization time, postoperative pain, and rehabilitation can be reduced by a smaller incision with less collateral tissue damage, the actual surgical intervention, ie, replacing the hip joint by a total joint arthroplasty is not minimized. Similarly, minimally invasive spine fusion is a misnomer because the final result is an arthrodesis [fusion], which can only cynically be regarded as minimally invasive. Minimally invasive surgeries are often associated even with higher perioperative risks at least in the learning curve…”
Norbert Boos, MD. Spine 2008;33(24): 2662
Criteria
Not Satisfactory
The story makes no mention of costs. The average hospital charges for a single-level fusion is about $50,000, exclusive of surgeon fees, rehab costs, and related costs such as time lost from work. The addition of screws or and a “bone growth material” adds thousands more. Not trivial issues.
Not Satisfactory
This broadcast falls down in virtually every possible way, but stands out for failing to address the most important reason for having spine surgery. The story doesn’t say what the outcome of surgery was for the patient interviewed or anyone else in the medical literature, other than to point out that the operation went like clockwork and the patient was heading home by 2:00 in the afternoon of the day she had the surgery. Although this is one outcome that some people care about, it says nothing about the reason she had the operation—to improve daily, disabling pain.
Not Satisfactory
The fusion procedure described in this story would appear to be nearly risk-free. Is exposure to “more than 200 x-rays” harmless because it is purportedly less radiation than a CT scan? Is there independent evidence to support the broadcast’s claim that a minimally invasive procedure cuts “no muscles or nerves”? Is there any evidence to suggest colon perforation is the only potentially serious complication? It seems unlikely, even if colon perforation is more common with the new procedure than with traditional fusion. What of the other complications that afflict people who have standard fusions? A large body of evidence has documented serious complications, including blood clots in the lung (pulmonary embolism), respiratory failure, cardiac arrest, stroke, nerve injury, and death. On average, these affect between 2% and 5% of patients (sometimes less, sometimes much more). Less serious complications abound (10% to 20% of fusions require a transfusion, another 10% tear the protective cover around the nerves). About 1 in 5 fusion operations fail. When it comes to minimally invasive surgery in other areas of orthopaedic and spine surgery, past is often prologue. It’s fine that the benefits outweighed the risks for the patient in this broadcast, but we hope she had a better understanding of the potential risks and benefits than the people watching this news segment.
Not Satisfactory
This major network broadcast–-about a major surgical procedure that is purported to help people hundreds of thousands of people with common low back pain–is devoid of evidence.
Not Satisfactory
The story says 250,000 Americans have fusions annually, and clearly suggests that chronic low back pain is an appropriate indication for fusion surgery. This conflicts with the evidence and expert consensus. Many leading researchers now say that nonspecific chronic low back pain is not an indication for surgery. Indeed, they say the indications are usually narrow—perhaps helpful in people with relatively uncommon conditions such degenerative spondylolisthesis (in which the vertebra shifts forward over the disc) and spinal deformities such as scoliosis.
Not Satisfactory
The broadcast includes interviews with one patient and three doctors. It makes no attempt to identify the experts’ potential conflicts of interest or balance their enthusiastic support for minimally invasive fusion with the views of other experts.
Not Satisfactory
The story mentions one alternative (standard fusion) once. It describes differences in surgical approaches and recovery time (hours vs. days). But the story overlooks arguably the most important alternative treatment—nonsurgical care. Randomized trials since 2003 have compared fusion to nonsurgical programs that combine a graduated exercise program with cognitive behavioral therapy. They suggest that people with chronic low back pain often do as well with nonsurgical care as with fusion, with fewer complications and lower costs. Recent international evidence-based guidelines recommend that all patients participate in such a program before they consider surgery.
Not Satisfactory
The story says minimally invasive fusion is FDA approved. Unfortunately, it fails to say precisely what that means. Is the FDA approval for a device? If so, which device—the screws used to reinforce the fusion, or the “bone growth material” that purportedly aids the fusion? Was the approval based on the procedure being no worse than the usual treatment (standard fusion)? Was the approval based on durable results over a long period of time? If it was compared against “usual” treatment (e.g. standard fusion), has the usual treatment be shown to be safe and effective? If so, in whom?
Satisfactory
The broadcast explains that the new, less invasive fusion procedure uses a different surgical approach than standard fusion.
Satisfactory
This story does not appear to rely solely or largely on a news release.
Total Score: 2 of 10 Satisfactory
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