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OR Manager Vol. 20 No. 4 April 2004

Is spinal fusion overused?

ost spinal fusion surgery is being done without clear evidence that it benefits patients, according to an opinion piece in the Feb 12 New MEngland Journal of Medicine. About 75% of spinal fusions now are done for reasons such as disk disorders that are beyond the original indications and aren’t backed by enough research. The authors conclude the costly procedure may be overused. The annual number of spinal fusions has been rising rapidly—by 77% between 1996 and 2001—compared with 13% to 14% for hip and knee replacements. Expensive spinal implants like pedicle Numbers of spinal fusion, knee , screws and cages, which can add thousands of and in the US dollars to a case, also have been introduced without much in the way of research, accord- ing to Richard A. Deyo, MD, professor of med- 450,000 icine at the University of Washington, Seattle, 400,000 and his colleagues. 350,000 Knee arthroplasty 300,000 Time to step back? 250,000 Hip replacement “It seems that it’s appropriate to step back (total and partial) 200,000 and ask, ‘Is it really wise to be using instru- 150,000 mentation as routinely as we do,’ if we can’t Spinal fusion demonstrate any benefit to patients in terms of No. of operations 100,000 pain relief or function, and if the costs are high- 50,000 er and the complications are higher,” Dr Deyo 0 1993 1994 1995 1996 1997 1998 1999 2000 2001 told OR Manager. One example is instrumented and noninstru- Data are from the Agency for Healthcare Research and Quality. mented fusions. Though several randomized tri- Source: Deyo R A et al. N Engl J Med. Feb 12, 2004; 350: 722-726. Copyright © 2004. als show instrumented fusions had a slightly Massachusetts Medical Society. All rights reserved. higher rate of solid fusions, “It’s not clear at all that they result in any better pain relief or patient functioning,” he said. “And in most cases, the use of implants seems to be associat- ed with more complications.” As evidence that spinal fusions are overused, the authors point to wide varia- tions in use of the procedure around the country—in New England rates vary 10- fold from one place to another, according to a 1995 report—rapidly rising rates of surgery, high rates of reoperation, and high rates of complications. If evidence-based practice was followed, spinal fusion might be reserved for and only rarely performed for disk herniation or with spondylolisthesis, they say.

Recommendations for change The authors make several recommendations. Among them are better alignment of financial incentives with data on the effi- cacy of fusions and stepped-up regulation by the Food and Drug Admini-stra- tion. On the financial aspects, Dr Deyo said he didn’t have a specific proposal but is concerned “that in a sense surgeons are being paid the best for doing proce- dures where there arguably is the least evidence of benefit for patients.” He noted that spine surgeons have a higher income than other orthopedic and neurosur- geons and that spinal fusions pay better than other types of spinal procedures. The authors also advocate that the FDA require “more rigorous research” on spinal devices before they are introduced; for instance, looking at whether the 1 OR Manager Vol. 20 No. 4 April 2004

devices yield better pain relief and function in addition to a better solid fusion rate. What about new technologies like morphogenic protein (BMP)? “I think we need more evidence on these things,” he said. “In the case of BMP, at least there are some randomized trials to support its use, although they are very small trials and relatively short-term. I think it is not so clear what the long- term benefits will be and whether the benefit is worth the cost.” The authors advised similar caution on other new technologies, such as artifi- cial disks, electrothermal therapy, analgesic pumps, and implanted spinal stimu- lators. They also advise caution on new spinal implants like artificial disks. How could their article help value analysis teams in the OR? Dr Deyo said, “Many of the things are probably things people think about and already do to some extent—such as trying to standardize implants as much as possible.” he said. Another suggestion is tougher: looking to see whether surgeons recommend- ing new devices have financial conflicts of interest. “I think it’s worth it—unpleasant though it may be—for a hospital adminis- trator to ask, ‘Is the surgeon getting consulting fees from the company that makes the device? Or is this really a disinterested recommendation?’” ❖

References Deyo R A, Nachemson A, Mirza S K. Spinal-fusion surgery: The case for restraint. N Engl J Med. Feb 12, 2004; 350:722-726. Katz J N. Lumbar spinal fusion: Surgical rates, costs, and complications. Spine. 1995;20:785-835. Kuntz K M, Snider R K, Weinstein J N, et al. Cost-effectiveness of fusion with and without instrumentation for patients with degenerative spondylolisthesis and spinal stenosis. Spine. 2000;25:1132-1139.

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