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Alan S. Hilibrand, MD

AAOS Now

Published 4/1/2012
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Mary Ann Porucznik

SPORT Results Are Good News for Spine Patients

Appropriate surgery is helpful, cost-effective, and provides lasting results

The Spine Patient Outcomes Research Trial (SPORT), a multicenter, randomized controlled trial, studied the outcomes of the surgical and nonsurgical management of three conditions: intervertebral disk herniation (IDH), degenerative spondylolisthesis (DS), and lumbar spinal stenosis (SPS). In its initial design, SPORT stirred some controversy by establishing both a randomized controlled trial and an observational cohort, by permitting crossover between surgical and nonsurgical treatments, and by reporting results based on both observational and intent-to-treat analyses.

Despite the lack of common protocols for both surgical and nonsurgical treatment, the SPORT study design has since been recognized as providing a high level of evidence for treatment of these three types of spinal disorders. “The Impact of the Spine Patient Outcomes Research Trial (SPORT) Results on Orthopaedic Practice,” which appears in the April Journal of the AAOS, reviews results at 4 years. In an interview with AAOS Now, authors Ferhan A. Asghar, MD, and Alan S. Hilibrand, MD, discussed the impact of SPORT.


Ferhan A. Asghar, MD

AAOS Now: Why are the results from the SPORT study so significant?

Dr. Asghar: The controversy over the kind of treatment—nonsurgical or surgical—that really works in a large population of patients with back and neck problems is ongoing. In the current cost-conscious environment, we as orthopaedic surgeons need to make sure we are providing appropriate, cost-effective treatment for people with spinal conditions. SPORT really helped in showing that lumbar spinal surgery helps patients with these problems.

The study looked at different outcome measures—including return to work, degree of activity, use of pain medications, and back and leg pain. Across each of the arms of the study—IDH, DS, and SPS—patients treated surgically tended to do better than those treated nonsurgically for up to 4 years.

Dr. Hilibrand: The prevailing wisdom among both orthopaedic surgeons and nonsurgeons, for the past 25 years, has been that patients with IDH do the same, whether or not they have surgery; they just get better faster with surgery. What SPORT says is that patients with IDH who are treated nonsurgically do get better in most instances, but not to the same level as those who have surgery. Now, 4 years out, those data are consistent, meaning that the groups are not the same. Patients treated surgically are still doing better than those treated nonsurgically.

AAOS Now: Why wasn’t this difference noticed earlier?

Dr. Hilibrand: Older studies didn’t follow enough patients for long enough and didn’t really provide the same level of detail on how patients were doing. Older studies also didn’t follow patients based upon the actual treatment they received; they followed them based upon whichever group they were put in. So results for all patients assigned to a nonsurgical treatment group would be considered “nonsurgical outcomes” even if some patients had surgery during the study period.

Another interesting point of the SPORT study is that among older patients with DS or SPS, those who didn’t have surgery had very little improvement in their Oswestry Disability Index. In surgical patients in both of those groups, the improvement that was seen at 6 months and at 1 year was pretty much maintained out to 4 years without much deterioration in outcomes.

AAOS Now: Do you anticipate that these results will make a difference in the way orthopaedic surgeons treat patients who have these conditions?

Dr. Asghar: Both national media and payers are putting the spotlight on orthopaedic surgery. We know that some patients do not do well with spine surgery and that patient selection is important. Take the patient who has back pain and refractory leg pain that doesn’t respond to appropriate nonsurgical treatment—including physical therapy, epidural injections, various medications, and just plain giving it time. SPORT tells us that surgery could give that patient a chance for improvement that will be maintained through the years.

Alan S. Hilibrand, MD

Another issue is the timing of surgery. People have had some concerns about whether treating a patient with a large disk herniation nonsurgically for 2 or 3 months would result in a poorer outcome—a neurologic deficit or bladder-control problems or cauda equina syndrome. What we saw with SPORT was that waiting and allowing a patient to give nonsurgical treatment the maximum chance doesn’t lead to those harmful ends.

On the other hand, the patient with intolerable sciatica could go ahead and have surgery; the rate of devastating complications associated with surgery is very low. We didn’t see a high incidence of paralysis or foot drop that could occur with an operation.

AAOS Now: Do these results address recent accusations by the media and policymakers that spine surgery is being misused or overused?

Dr. Hilibrand: I do believe that insurance companies are responding to these results by approving spine surgery if the patient has one of these conditions, has met the criteria established by SPORT for nonsurgical treatment, and continues to experience pain and disability. For example, most insurers now agree that degenerative spondylolisthesis is an indication for spinal fusion, in part because, in the SPORT study, 90 percent of the patients in the DS group had fusion and had very impressive outcomes.

One other point I would make relates to the importance of the data from SPORT. No other orthopaedic study received more funding from the National Institutes of Health than SPORT and no other study has monitored spending on patient care as meticulously. Credit should be given to James N. Weinstein, DO, and his group at Dartmouth for thinking through and documenting every dollar spent on patient care during this study.

As a result, we now have very precise cost-effectiveness data for these spine treatments, measured in quality-adjusted life years (QALYs), which is a way to assess the utility or value of an operation for a patient. For example, among patients in the DS group, at 2 years, the cost per QALY was about $116,000. Now, at the 4-year data point, that number is down to about $60,000/QALY. Because these surgical outcomes are durable, as we follow these patients for longer and longer—our goal is to follow them for at least 10 years—we are showing how cost effective surgical treatment is. That will be very important if payers set a bar, as has been done in other countries, that will only allow surgical treatments with a cost per QALY below a certain number.

AAOS Now: But at that point, wouldn’t patient age be a factor?

Dr. Hilibrand: I don’t think so. I think that most of these patients will live 10 years, and most had surgery in their 60s; I think the average age was 63 years old. Interestingly, in some arms of the study, patients who had surgery are actually living longer than those who didn’t. Not that the surgery saves or lengthens lives, but to the extent that it improves the quality of life and the level of physical function, surgery may have some long-term benefits in terms of people living longer.

AAOS Now: Do you have any advice for orthopaedic surgeons who are not spine surgeons, who are referring their patients, to help them identify good candidates for surgery?

Dr. Asghar: In general, patients have a sense of what direction they’re headed. Someone with a disk herniation that looks terrible on an MRI scan may respond very well to a couple of weeks of medication and an epidural injection. Another patient with a similar MRI scan may not respond to treatment and may beg for help. That’s the patient who will need surgery. Of course, we as orthopaedic surgeons must counsel our patients appropriately about the risks of proceeding to surgery or waiting, but we only have 20 minutes in an exam room to get a very small snapshot of what their lives are like. Patients and their families who see how they’re handling their lives have a much better sense for what they want to do.

Dr. Hilibrand: Prior to this study, some papers looking at patient preferences had been published. They found that when patient preferences drove treatment, outcomes improved. People who have an idea of what kind of care they want, to the extent that they can be accommodated, recognize that they’re getting better or they’re not getting better. Orthopaedic surgeons need to engage patients in “shared decision-making” and let patients judge for themselves.

Disclosure information: Dr. Asghar—no conflicts. Dr. Hilibrand—Aesculap/B.Braun; Alphatec Spine; Amedica; Biomet; Stryker; Zimmer; Benvenue Medical; Lifespine; Nexgen; Paradigm Spine; Pioneer Surgical; PSD; Spinal Ventures; Syndicom; Vertiflex; Journal of Bone and Joint Surgery–American; Journal of the AAOS

Mary Ann Porucznik is the managing editor of AAOS Now; she can be reached at porucznik@aaos.org