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compared to improvement of 26 percent and 25 percent, respectively, for patients treated with conservative care. Over the course of two years the treatment effects narrowed, but surgery was statistically significantly better at all treatment time points. Not only was surgery better than conservative care, but this difference was maintained out to four years in follow-up studies (Weinstein et al., 2008, Spine 33(25): 2789– 2800). Spinal stenosis To be included in the spinal stenosis trial, patients had to have had at least 12 weeks of symptoms; imaging showing spinal stenosis without spondylolisthesis at one or more segments; and been judged to be surgical candidates (Weinstein et al., 2008, N Engl J Med
358:794–810). Nonsurgical care prior to study enrollment included physical therapy, epidural injections, chiropractic care, anti-inflammatories, and opioid analgesics. The study was organized into both a randomized and an observational cohort; 289 patients were enrolled in the randomized study, and 365 patients were enrolled in the observational cohort. In the randomized cohort, there was considerable crossover. In the surgery group, only 63 percent of patients had undergone surgery at one year and 67 percent at two years. In the nonsurgical group, 42 percent had undergone surgery at one year and 43 percent at two years. A full one-third of patients who were felt eligible for surgery did not proceed with it. Patients who crossed over from surgery to nonsurgical care had less
Key messages Patients with a herniated disc and at least six weeks of symptoms have a better outcome with surgical treatment at two years than patients treated only with conservative care, and that difference is maintained through four years. Patients with spinal stenosis who have had at least three months of symptoms have a better outcome with surgical treatment at two years than patients treated with conservative care, and that difference is maintained through four years. Patients with spondylolisthesis and stenosis who have had at least three months of symptoms have a better outcome with surgical treatment at two years than patients treated with conservative care, and that difference is maintained through four years.
bothersome symptoms and were less likely to rate their symptoms as worsening than patients who remained in the surgery group. This does not represent a failure of surgical care, but rather patient choice. The 43 percent of patients who crossed over from nonsurgical care to surgery likely represents a failure of conservative care for these patients. However, in the intention-to-treat analysis, they were treated as if they did not have surgery, even though they did. Despite the neutralization effect of the crossover in this study, there was a significant treatment effect favoring surgery at two years, even with the intention-to-treat analysis. However, ODI and SF-36 changes were not statistically significant. Findings. Both the observational cohort and the as-treated analysis showed statistically significantly better improvements in all outcome measures at all time points in surgery patients as compared to patients who received usual conservative care. At two years, 72 percent of surgery patients reported a major improvement in symptoms, as compared to 20 percent of nonsurgical patients. ODI scores improved by 21 points in surgery patients and by 7.6 points in nonsurgical patients. Similar trends were seen for SF36 scores, stenosis bothersome index, leg pain bothersomeness scale, and low-back-pain bothersomeness scale.
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The data conclusively demonstrate superiority of surgery as compared to nonsurgical care for patients with spinal stenosis without spondylolisthesis who have failed three months of conservative care and are judged to
be surgical candidates (Weinstein et al., 2008, N Engl J Med, op cit.). Four-year follow-up data demonstrate that the advantage of surgical treatment is maintained (Weinstein et al., 2010, op cit.). Degenerative spondylolisthesis To be included in the degenerative spondylolisthesis trial, patients had to have neuroclaudication symptoms or radicular leg pain; spinal stenosis on imaging; degenerative spondylolisthesis on a standing lateral X-ray; had symptoms for 12 weeks; and been judged to be a surgical candidate (Weinstein et al., 2007, N Engl J Med 356:2257–70). Conservative treatments prior to surgery included physical therapy (68 percent), lumbar epidural injections (55 percent), chiropractic care (25 percent), anti-inflammatories (63 percent), and opioid analgesics (30 percent). Interventions included either surgical care with a decompressive laminectomy (with or without a fusion, with or without instrumentation) versus usual care, including at least physical therapy and anti-inflammatory medications. As in the stenosis trial, patients were divided into a randomized “intent to treat” trial, and those who did not wish to be randomized were placed into an observational cohort. In the randomized cohort, 159 patients were assigned to surgery and 145 patients were assigned to nonsurgical care. Sixty-four percent of patients assigned to surgery underwent surgery within two years, meaning that 36 percent of patients crossed Spine Outcomes Research Trial to page 36