Background Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials. Methods Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S. spine clinics. Treatment was decompressive surgery or usual nonsurgical care. The primary outcomes were measures of bodily pain and physical function on the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36) and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and 1 and 2 years. Results A total of 289 patients were enrolled in the randomized cohort, and 365 patients were enrolled in the observational cohort. At 2 years, 67% of patients who were randomly assigned to surgery had undergone surgery, whereas 43% of those who were randomly assigned to receive nonsurgical care had also undergone surgery. Despite the high level of nonadherence, the intention-to-treat analysis of the randomized cohort showed a significant treatment effect favoring surgery on the SF-36 scale for bodily pain, with a mean difference in change from baseline of 7.8 (95% confidence interval, 1.5 to 14.1); however, there was no significant difference in scores on physical function or on the Oswestry Disability Index. The as-treated analysis, which combined both cohorts and was adjusted for potential confounders, showed a significant advantage for surgery by 3 months for all primary outcomes; these changes remained significant at 2 years. Conclusions In the combined as-treated analysis, patients who underwent surgery showed significantly more improvement in all primary outcomes than did patients who were treated nonsurgically.

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Study Design-Repeated cross-sectional analysis using national Medicare data from the Dartmouth Atlas Project.Objectives-To describe recent trends and geographic variation in population-based rates of lumbar fusion spine surgery.Summary of Background Data-Lumbar fusion rates have increased dramatically during the 80s and even more so in the 90s. The most rapid increase appeared to follow the approval of a new surgical implant device.Methods-Medicare claims and enrollment data were used to calculate age-, sex-and raceadjusted rates of lumbar laminectomy/discectomy and lumbar fusion for fee-for-service Medicare beneficiaries over age 65 in each of the 306 U.S. Hospital Referral Regions between 1992 and 2003. Conclusions-The rate of specific procedures within a region or "surgical signature" is remarkably stable over time. However, there has been a marked increase in rates of fusion and a coincident shift and increase in cost. Rates of back surgery were not correlated with the per-capita supply of orthopaedic and neurosurgeons. Results-Lumbar

Study Design Randomized trial and concurrent observational cohort study Objective To compare 4 year outcomes of surgery to non-operative care for spinal stenosis. Summary of Background Data Surgery for spinal stenosis has been shown to be more effective compared to non-operative treatment over two years, but longer-term data have not been analyzed. Methods Surgical candidates from 13 centers in 11 U.S. states with at least 12 weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort (RC) or observational cohort (OC). Treatment was standard decompressive laminectomy or standard non-operative care. Primary outcomes were SF-36 bodily pain (BP) and physical function (PF) scales and the modified Oswestry Disability index (ODI) assessed at 6 weeks, 3 months, 6 months and yearly up to 4 years. Results 289 patients enrolled in the RC and 365 patients enrolled in the OC. An as-treated analysis combining the RC and OC and adjusting for potential confounders found that the clinically significant advantages for surgery previously reported were maintained through 4 years, with treatment effects (defined as mean change in surgery group minus mean change in non-op group) for BP 12.6 (95% CI, 8.5 to 16.7); PF 8.6 (95% CI, 4.6 to 12.6); and ODI −9.4 (95% CI, −12.6, to −6.2). Early advantages for surgical treatment for secondary measures such as bothersomeness, satisfaction with symptoms and self-rated progress also were maintained. Conclusions Patients with symptomatic spinal stenosis treated surgically compared to those treated non-operatively maintain substantially greater improvement in pain and function through four years.

clinicaltrials.gov Identifier: NCT00000410.

Lumbar spinal stenosis (LSS) affects more than 200,000 adults in the United States, resulting in substantial pain and disability. It is the most common reason for spinal surgery in patients over 65 years. Lumbar spinal stenosis is a clinical syndrome of pain in the buttocks or lower extremities, with or without back pain. It is associated with reduced space available for the neural and vascular elements of the lumbar spine. The condition is often exacerbated by standing, walking, or lumbar extension and relieved by forward flexion, sitting, or recumbency. Clinical care and research into lumbar spinal stenosis is complicated by the heterogeneity of the condition, the lack of standard criteria for diagnosis and inclusion in studies, and high rates of anatomic stenosis on imaging studies in older people who are completely asymptomatic. The options for non-surgical management include drugs, physiotherapy, spinal injections, lifestyle modification, and multidisciplinary rehabilitation. However, few high quality randomized trials have looked at conservative management. A systematic review concluded that there is insufficient evidence to recommend any specific type of non-surgical treatment. Several different surgical procedures are used to treat patients who do not improve with non-operative therapies. Given that rapid deterioration is rare and that symptoms often wax and wane or gradually improve, surgery is almost always elective and considered only if sufficiently bothersome symptoms persist despite trials of less invasive interventions. Outcomes (leg pain and disability) seem to be better for surgery than for non-operative treatment, but the evidence is heterogeneous and often of limited quality.

Surgery for IDH was moderately cost-effective when evaluated over 2 years. The estimated economic value of surgery varied considerably according to the method used for assigning surgical costs.

clinicaltrials.gov Identifier: NCT00000410.