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].)

Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis.

BACKGROUND: Management of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials. METHODS: Surgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years. RESULTS: We enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment. CONCLUSIONS: In nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].)

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

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 (Ϫ38.1 vs. Ϫ24.9; Ϫ13.2; Ϫ15.6 to Ϫ10.9). 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. Key words: SPORT, intervertebral disc herniation, surgery, nonoperative care, outcomes. Spine 2008;33:2789-2800 Lumbar disc surgery remains one of the most commonly performed operations, with rates exhibiting considerable geographic variation. 1 Two recent randomized trials demonstrated that surgery provides faster pain relief and perceived recovery in patients with herniated disc. 2-4 Outcomes were similar at 1 year for patients assigned to surgery and for those assigned to nonoperative treatment. However, both trials included substantial numbers of surgical patients in the nonoperative comparison arm due to treatment crossover, affecting the interpretation of the intent-to-treat analyses. This paper reports 4-year results for SPORT based on the continued follow-up of the herniated disc randomized and observational cohorts. Materials and Methods Study Design SPORT was conducted in 11 US states at 13 medical centers with multidisciplinary spine practices. The human subjects committees at each participating institution approved a standardized protocol for both the observational and the randomized cohorts. Patient inclusion and exclusion criteria, study interventions, outcome measures, and follow-up procedures have been reported previously. 3-5 Patient Population Men and women who had symptoms and confirmatory signs of lumbar radiculopathy that persisted for at least 6 weeks, who had disc herniation at a corresponding level and side on imaging, and who were considered surgical candidates were eligible. The content of pre-enrollment nonoperative care was not prespecified in the protocol. 3-5 Specific enrollment and exclusion criteria are reported elsewhere

Lateral Transpsoas Fusion: Indications and Outcomes

Spinal fusion historically has been used extensively, and, recently, the lateral transpsoas approach to the thoracic and lumbar spine has become an increasingly common method to achieve fusion. Recent literature on this approach has elucidated its advantage over more traditional anterior and posterior approaches, which include a smaller tissue dissection, potentially lower blood loss, no need for an access surgeon, and a shorter hospital stay. Indications for the procedure have now expanded to include degenerative disc disease, spinal stenosis, degenerative scoliosis, nonunion, trauma, infection, and low-grade spondylolisthesis. Lateral interbody fusion has a similar if not lower rate of complications compared to traditional anterior and posterior approaches to interbody fusion. However, lateral interbody fusion has unique complications that include transient neurologic symptoms, motor deficits, and neural injuries that range from 1 to 60% in the literature. Additional studies are required to further evaluate and monitor the short- and long-term safety, efficacy, outcomes, and complications of lateral transpsoas procedures

The cientificWorldJOURNAL Review Article Lateral Transpsoas Fusion: Indications and Outcomes

Spinal fusion historically has been used extensively, and, recently, the lateral transpsoas approach to the thoracic and lumbar spine has become an increasingly common method to achieve fusion. Recent literature on this approach has elucidated its advantage over more traditional anterior and posterior approaches, which include a smaller tissue dissection, potentially lower blood loss, no need for an access surgeon, and a shorter hospital stay. Indications for the procedure have now expanded to include degenerative disc disease, spinal stenosis, degenerative scoliosis, nonunion, trauma, infection, and low-grade spondylolisthesis. Lateral interbody fusion has a similar if not lower rate of complications compared to traditional anterior and posterior approaches to interbody fusion. However, lateral interbody fusion has unique complications that include transient neurologic symptoms, motor deficits, and neural injuries that range from 1 to 60% in the literature. Additional studies are required to further evaluate and monitor the short-and long-term safety, efficacy, outcomes, and complications of lateral transpsoas procedures