Jon D. Lurie

Surgical versus nonsurgical therapy for lumbar spinal stenosis.

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. (ClinicalTrials.gov number, NCT00000411 [ClinicalTrials.gov].).

United States Trends and Regional Variations in Lumbar Spine Surgery: 1992–2003

Study Design. Repeated cross-sectional analysis using national Medicare data from the Dartmouth Atlas Project. Objective. 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 1980s and even more so in the 1990s. 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 race-adjusted rates of lumbar laminectomy/discectomy and lumbar fusion for fee-for-service Medicare beneficiaries over age 65 in each of the 306 US Hospital Referral Regions between 1992 and 2003. Results. Lumbar fusion rates have increased steadily since 1992 (0.3 per 1000 enrollees in 1992 to 1.1 per 1000 enrollees in 2003). Regional rates of lumbar discectomy, laminectomy, and fusion in 1992–1993 were highly correlated to rates of discectomy, laminectomy (R2 = 0.44), and fusion (R2 = 0.28) in 2002–2003. There was a nearly 8-fold variation in regional rates of lumbar discectomy and laminectomy in 2002 and 2003. In the case of lumbar fusion, there was nearly a 20-fold range in rates among Medicare enrollees in 2002 and 2003. This represents the largest coefficient of variation seen with any surgical procedure. Medicare spending for inpatient back surgery more than doubled over the decade. Spending for lumbar fusion increased more than 500%, from

Surgical Versus Nonoperative Treatment for Lumbar Disc Herniation Four-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

75 million to

Surgical versus nonoperative treatment for lumbar spinal stenosis four-year results of the Spine Patient Outcomes Research Trial.

482 million. In 1992, lumbar fusion represented 14% of total spending for back surgery; by 2003, lumbar fusion accounted for 47% of spending. 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 orthopedic and neurosurgeons.

Surgical Treatment of Spinal Stenosis with and without Degenerative Spondylolisthesis: Cost-Effectiveness after 2 Years

Study Design. Concurrent, prospective, randomized, and observational cohort study. Objective. To assess the 4-year outcomes of surgery versus nonoperative care. Summary of Background Data. Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to nonoperative treatment remain controversial. Methods. Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective, randomized (501 participants), and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual nonoperative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 months, 6 months, and annually thereafter. Results. Nonadherence to treatment assignment caused the intent-to-treat analyses to underestimate the treatment effects. In the 4-year combined as-treated analysis, those receiving surgery demonstrated significantly greater improvement in all the primary outcome measures (mean change surgery vs. nonoperative; treatment effect; 95% CI): BP (45.6 vs. 30.7; 15.0; 11.8 to 18.1), PF (44.6 vs. 29.7; 14.9;12.0 to 17.8) and ODI (−38.1 vs. −24.9; −13.2; −15.6 to −10.9). The percent working was similar between the surgery and nonoperative groups, 84.4% versus 78.4% respectively. Conclusion. In a combined as-treated analysis at 4 years, patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperatively treated patients in all primary and secondary outcomes except work status.

Design of the Spine Patient outcomes Research Trial (SPORT).

Study Design. Randomized trial and concurrent observational cohort study. Objective. To compare 4 year outcomes of surgery to nonoperative care for spinal stenosis. Summary of Background Data. Surgery for spinal stenosis has been shown to be more effective compared to nonoperative treatment over 2 years, but longer-term data have not been analyzed. Methods. Surgical candidates from 13 centers in 11 US 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 nonoperative care. Primary outcomes were SF-36 bodily pain (BP) and physical function scales and the modified Oswestry Disability index assessed at 6 weeks, 3 months, 6 months, and yearly up to 4 years. Results. A total of 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 nonoperative group) for bodily pain 12.6 (95% confidence interval [CI], 8.5–16.7); physical function 8.6 (95% CI, 4.6–12.6); and Oswestry Disability index −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 were also maintained. Conclusion. Patients with symptomatic spinal stenosis treated surgically compared to those treated nonoperatively maintain substantially greater improvement in pain and function through 4 years.

Rates of advanced spinal imaging and spine surgery.

BACKGROUND The SPORT (Spine Patient Outcomes Research Trial) reported favorable surgery outcomes over 2 years among patients with stenosis with and without degenerative spondylolisthesis, but the economic value of these surgeries is uncertain. OBJECTIVE To assess the short-term cost-effectiveness of spine surgery relative to nonoperative care for stenosis alone and for stenosis with spondylolisthesis. DESIGN Prospective cohort study. DATA SOURCES Resource utilization, productivity, and EuroQol EQ-5D score measured at 6 weeks and at 3, 6, 12, and 24 months after treatment among SPORT participants. TARGET POPULATION Patients with image-confirmed spinal stenosis, with and without degenerative spondylolisthesis. TIME HORIZON 2 years. PERSPECTIVE Societal. INTERVENTION Nonoperative care or surgery (primarily decompressive laminectomy for stenosis and decompressive laminectomy with fusion for stenosis associated with degenerative spondylolisthesis). OUTCOME MEASURES Cost per quality-adjusted life-year (QALY) gained. RESULTS OF BASE-CASE ANALYSIS Among 634 patients with stenosis, 394 (62%) had surgery, most often decompressive laminectomy (320 of 394 [81%]). Stenosis surgeries improved health to a greater extent than nonoperative care (QALY gain, 0.17 [95% CI, 0.12 to 0.22]) at a cost of

The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT).

77,600 (CI,

Is a Condition-Specific Instrument for Patients with Low Back Pain/Leg Symptoms Really Necessary? : The Responsiveness of the Oswestry Disability Index, MODEMS, and the SF-36

49,600 to

The Influence of Obesity on the Outcome of Treatment of Lumbar Disc Herniation: Analysis of the Spine Patient Outcomes Research Trial (SPORT)

120,000) per QALY gained. Among 601 patients with degenerative spondylolisthesis, 368 (61%) had surgery, most including fusion (344 of 368 [93%]) and most with instrumentation (269 of 344 [78%]). Degenerative spondylolisthesis surgeries significantly improved health versus nonoperative care (QALY gain, 0.23 [CI, 0.19 to 0.27]), at a cost of