Re-operation rates post spinal fusion are over 20%!

Here is yet another study supporting the notion that one of a physical therapist's primarily responsibility should be protecting consumers from spine surgeons. This study just published in Spine suggests that re-operation rates post spinal fusion are in upwards of 20%. What a great procedure if I am a spine surgeon! I can be guaranteed that I will get to re-surgerize at least 1 in 5 of my patients. And when that doesn't work, I can implant an artificial disk (which of course may be worse than a fusion), guaranteeing me a minimum of at least 3 procedures over the patient's lifetime and an extremely lucrative revenue stream to boot. The conclusion from this study is clear:

Patients should be informed that the likelihood of re-operation following a lumbar spine operation is substantial.

Consider the alternatives proposed by the Association of Ethical Spine Surgeons, who understand that lumbar surgery rates in the U.S. is preposterously over-utilized and that spine surgeons are some of the biggest investors in device manufacturing companies, not to mention extremely lucrative fees for using a particular manufacturer's hardware. If you think your spine surgeon's recommendation that you need an instrumented fusion has anything to do with your back, you may be sorely mistaken. Financial conflicts of interest offer pernicious incentives to surgerize, surgerize, and surgerize some more, making spine surgery one of the most lucrative areas in medicine. Is 'spinal prostitution' too strong of language to describe the landscape of spinal surgery in the U.S.?

Consumers would do well to heed the AAOMPT's mantra for the year...go see your physical therapist because we will not prescribe drugs or perform invasive procedures that may well cause more harm than good.

John

Comments

[britt smith]

John,
The long view of the spinal fusion story is that the patients (and society) are not getting much of a bang for their risk and $$$. Spinal fusion has increased in frequency/population in the US exponentially: Spending for lumbar fusion increased more than 500%, from 75 million dollars to 482 million dollars. Lumbar fusion in 1992 represented 14% of total spending for back surgery; by 2003, lumbar fusion accounted for 47% of spending. [Weinstein JN, Lurie JD, Olson PR, Bronner KK, Fisher ES .United States’ trends and regional variations in lumbar spine surgery: 1992-2003. Spine. 2006 Nov 1;31(23):2707-14.] During the period from 1997 to 2003, and lumbar fusion increased from 42 per 100,000 to 108 per 100,000 for patients 60 years and older (156% increase), as spinal fusion rose from the 41st most common inpatient procedure in 1997 to the 19th in 2003. [Cowan JA Jr, Dimick JB, Wainess R, Upchurch GR Jr, Chandler WF, La Marca F. Changes in the utilization of spinal fusion in the United States.Neurosurgery. 2006 Jul;59(1):15-20; discussion 15-20.]
Ibrahim et al performed a meta-analysis of the three recent RCTs comparing surgical fusion with non-surgical interventions [Fritzell et al. Spine, 2001, Brox et al. Spine 2003, Fairbank et al, BMJ, 2005]. The analysis compared mean differences in ODI from baseline to follow-up. The pooled mean difference in ODI between the surgical and non-surgical groups was in favor of surgery (mean difference of ODI: 4.13, 95%CI: -0.82 to 9.08, p = 0.10), but did not reach statistical significances and minimal clinical importance (i.e. Assume the TRUE value for the difference between surgery vs. non-surgery was the Far left side of the confidence interval...the ODI value was 9 points!!!). Fusion surgery was associated with a 16% pooled rate of early complication (95%CI: 12-20). The authors concluded that current cumulative evidence does not support routine surgical fusion for CLBP patients. [Ibrahim T, Tleyjeh IM, Gabbar O. Surgical versus non-surgical treatment of chronic low back pain: a meta-analysis of randomised trials.Int Orthop. 2006 Nov 21; [Epub ahead of print] Indeed, the study that drags the effect estimate strongly towards favoring surgery (Fritzell et al. 2001)has a non-surgical group of treatment as usual (what they had already failed). Kwon et al (Spine, 2006)suggest that Fritzell et al's use of ‘usual non-operative care’ was a low bar for comparison and the outcomes of the study should suggest fusion OR good cognitive behavioral care for CLBP patients with DDD.
Fairbank et al 2005 found the Oswestry (ODI) favored surgery by a mean of (-) 4.1 (95% confidence interval -8.1 to -0.1, P = 0.045), with no other outcomes with significant difference between the groups at 2 years. Two outcomes reached minimal clinically important differences (MCID)[the Oswestry mean of 4 points is generally not considered reaching MCID] and surgery poses additional risks and cost vs. the rehabilitation group. The authors question if the economic benefit from a marginal improvement outweights the risks of surgery vs. rehabilitation [Fairbank J, Frost H, Wilson-MacDonald J, Yu LM, Barker K, Collins R; Spine Stabilisation Trial Group. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial.BMJ. 2005;330(7502):1233. Epub 2005 May 23. Erratum in: BMJ. 2005;330(7506):1485]
Koes’ commentary on the Fairbank et al in the British Medical Journal points to the continued lack of scientific support for spinal fusion in CLBP patients. He noted that although spinal fusion seems to help some patients with CLBP, “we must find ways to identify these patients in advance using valid and reliable classification systems. Until then spinal fusion may, after all these years, still be regarded as an experimental treatment. [italics added]” [Koes BW. Surgery versus intensive rehabilitation programmes for chronic low back pain. BMJ 2005;330:1220-1221]
Similarly, a systematic review by van Tulder et al 2006 concluded cognitive intervention with exercise first line intervention for CLBP. Fusion considered after 2 years. No difference in PL approach to fusion and more intensive interventions.[van Tulder MW, Koes B, Seitsalo S, Malmivaara A.Outcome of invasive treatment modalities on back pain and sciatica: an evidence-based review.Eur Spine J. 2006 Jan;15 Suppl 1:S82-92. Epub 2005 Dec 1.]Another caveate from the Fritzell et al 2001 study, which also compared instrumented vs. non-instrumented fusion: There was no difference in outcomes between the groups, but higher complication rates in instrumented fusions. The vast majority of fusions performed in the US are instrumented (estimates as high as 90% of all fusions).
....The bottom-line is the evidence supports that PT, cognitive behavioral approaches and exercise, AS THE FIRST LINE of care for chronic LBP. Most disturbing is the recent article by Weiner et al 2006 which showed a 0.2% increase in Medicare service charges in Pennsylvania in 2yrs (2000-2-4) AND.... 59.4% for injections, 41.9% for MRI/CT, and 19.3% for X rays. [Weiner DK, Kim YS, Bonino P, Wang T. Low back pain in older adults: are we utilizing healthcare resources wisely?Pain Med. 2006 Mar-Apr;7(2):143-50.]
Physical Therapy is UNDERUTILIZED for chronic LBP, and estimates of unnecessary back surgery range as high as 75-90%. Medicare billing for spinal surgery, alone, has reached $1 billion, and again, 47% are fusion surgeries....What are we going to do about it? We, physical therapists, need to speak up, organize and mobilize to get the TRUTH told.
Britt

[Carol]

John,
I am not a blogging regular, and my opinion differs in some ways from the majority of the bloggers. I think our overall intent is the same.
I was very interested in your post on spine surgery, because we work in the midst of a lot of it. Although there is no question there are some conflicts of interest, I think that other issues are key. There is a ton of professional jealousy between surgeons and nonsurgeons. The problem is that no one has the answers for many of the patients with chronic spine problems, and so there is a lot of blaming and what if going on. The proliferation of ineffective injections is part of the competition. But the problem for therapists, especially those who attempt to work with difficult spine patients is, we can’t claim a better success rate than anyone else. You know the evidence, and it is not there for us yet. The assumption made by the public currently is that there is a hierarchy and therapists are pretty much at the bottom of it, like it or not. The more risk you assume, the higher you are placed on the ladder, and you are paid accordingly. This is perceived as unfair, but it is a reality.
I actually do not think that most spine surgeons feel they are taking advantage of the system by supporting products they use. But there will always be people motivated primarily by money (there are more than just surgical products that have potential conflict of interest too), and it is kind of a waste of energy to point fingers, when no one yet has the answers for these patients. You may have noticed in the Association of Ethical Spine Surgeons website, there are very few names listed. A few have come forward publicly, but who is to say it is not for their own recognition and place at the top?
Spine pathologies are my primary interest in PT practice, and I follow a lot of the literature, but have found increasing amounts of conflicting information. I think it is wonderful that therapists have made strides with identifying important muscle recruitment techniques for spine patients and methods that help return function. Our classification systems offer some answers for better interventions. I think we are on the right track, but have a lot more work to do. And a population of patients we need to target include the substantial number of patients out there who decide to go for a quick fix (or what they think will be one), or are unwilling to work on physical changes, using the advertising slogan “I haven’t got time for the pain”. Their interests in PT are minimal. This group may actually be a majority of the population, so we must go after them if we are going to change any of the above. I don’t think that pitting ourselves against other professions will accomplish that.
Carol McFarland PT

[Jason Silvernail]

Hi Carol.
I don't think our approach to the overutilization of spine surgery should be to shrug our shoulders and essentially say "well, I don't have all the answers, either..."

If we are debating approaches which have similar risk-benefit curves than your argument makes sense. Given the what should now be considered overwhelming evidence of the questionable nature of fusion surgery, we simply cannot afford to sit back and see consumers offered such limited options. While you may be right that people are looking for a quick fix, I would consider a 4-6 course of PT to be pretty quick compared to the recovery time from spinal fusion.

I don't think anyone is suggesting "pitting ourselves against another profession", just voicing sensible and reasonable concerns about part of current medical practice, and how it might be improved -both in terms of outcomes and money.

[Jason Silvernail]

Sorry, my last post should read "...4-6 WEEK course of PT..."

[britt smith]

Carol,
I agree that surgeons are doing what they do best: Surgery. Most are very good people, VERY smart, VERY skilled and doing their best job. There are a few who have principle interests in $$$. Most surgeons are trying to distance themselves from these persons & problems of conflict-of-interest in sales of devices, such as the Medtronics debacle know as 'fusion-gate' (a few editorials in neurosurgery literature).
I agree with Jason, the evidence points toward a good, integrated program of rehabilitation: Multidisciplinary including exercise, behavioral/cognitive approaches as first line in cLBP care. My last point above, about chronic LBP patients in the Medicare population was a misprint: '...a 0.2% increase in Medicare service charges in Pennsylvania in 2yrs (2000-2-4)" should have read: 'a 0.2% increase in physical therapy charges to Medicare in 2 yrs (2000-2).' During this period of time, the spending going towards chronic back care saw the VAST majority of increases in injections, MRI/CT etc, NOT Physical therapy (0.2%). Of the cLBP patients surveyed, 61% had an MRI...NONE had a red flag for their condition, which is, again, contrary to the evidence. The problem PT faces at this time is not just the patients aren't seeing PTs (note: Whitman et al 2006 found that only 10% of patients in spinal stenosis studies had PT prior to their surgeries), the health care dollars are being squandered on useless, non-therapeutic monies, by the bushel-full. Jarvik et al. demonstrated that if you randomize patients to radiographs vs. MRI the patients had the same outcomes....except the MRI group had 3x higher surgical rates!!!! Spinal surgery billing for Medicare has reached $ 1 billion (47% is for fusion)...which I believe is double what is spent on PT in Medicare (all services).
We have a problem, here. PTs have to become a voice at the table in the discussion of how the chronic LBP patient should be treated. Thanks,
Britt

[Carol]

Hi Jason and Britt,
Thanks so much for your comments. I still am not convinced however, that we have the evidence behind us to support therapy over any other treatment. And believe me, I am not just shrugging my shoulders. I am at American Back Society every year, plugging the importance of specific reconditioning and functional training to somewhat ambivalent audiences of spine care professionals. I cite many of the sources you do and I have published a book on the importance of rehab for patients with surgical and nonsurgical spine procedures. The fact is, we still don't have the evidence we need to convince any of the other professions that we provide a service of value. I am slapped with this whenever I bring up this topic. I can quote just as many articles as any one else has cited that dispute our value in the system. (Carragee studies were some of the biggest blows we took) Until we are established as an integral part of spine care (which still has not happened completely), it is pretty useless criticizing others in the same arena who have been accepted. And thank you, Britt, for acknowledging that all surgeons aren't crooks!
Carol

[Britt]

Carol,
Agree all the way around on this issue. We don't have 'cultural authority' in the care of cLBP patients. Difficult problem, indeed, but I don't think building another type of implant or new resection of the anatomy is the answer to the majority of cLBP patients. Clearly, surgeons and PTs need to get better at identifying the subgroups of this population to that best fit a particular approach, be it surgical or non-surgical.
Britt

[Jason Silvernail]

I would agree with Britt, and also add that it isn't useless to criticize those involved in high-risk, low-yield procedures which have a questionable benefit.

If the patient's therapy doesn't work, what have we lost in terms of money and future prognosis?
If fusion surgery doesn't work, what have we lost?

We can't treat these interventions as the same or imply that everyone has an equal shot at helping the patient.
Clearly, large numbers of those with back pain are getting more invasive and more expensive procedures, many times before a gentler, cheaper, less-risky approach is even considered, much less tried.

If that's not a problem worthy of our attention and worth stepping on toes for, then I don't know what would be.
Jason.

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If we are debating approaches which have similar risk-benefit curves than your argument makes sense. Given the what should now be considered overwhelming evidence of the questionable nature of fusion surgery, we simply cannot afford to sit back and see consumers offered such limited options. While you may be right that people are looking for a quick fix, I would consider a 4-6 course of PT to be pretty quick compared to the recovery time from spinal fusion.