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      Superion ® InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial

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          Abstract

          Purpose

          This report provides the 3-year clinical outcomes from the randomized, controlled US Food and Drug Administration Investigational Device Exemption trial of the Superion ® for the treatment of moderate degenerative lumbar spinal stenosis.

          Patients and methods

          The Superion ® was evaluated in the treatment of subjects aged 45 years or older suffering from symptoms of intermittent neurogenic claudication, secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5. Patients were treated between June 2008 and December 2011 at 31 investigational sites. Three hundred ninety-one subjects were included in the randomized study group consisting of 190 Superion ® and 201 X-STOP ® control subjects. The primary composite endpoint was individual patient success based on four components: improvement in two of three domains of the Zurich Claudication Questionnaire, no reoperations at the index level, no major implant/procedure-related complications, and no clinically significant confounding treatments.

          Results

          At 3 years, the proportion of subjects achieving the primary composite endpoint was greater for Superion ® (63/120, 52.5%) than for X-STOP ® (49/129, 38.0%) ( P=0.023) and the corresponding success rates exceeded 80% for each of the individual components of the primary endpoint in the Superion ® group (range: 81%–91%). Improvements in back and leg pain severity as well as back- and disease-specific functional outcomes were also maintained through 36 months.

          Conclusion

          The 3-year outcomes from this randomized controlled trial demonstrate durable clinical improvement consistently across all clinical outcomes for the Superion ® in the treatment of patients with moderate degenerative lumbar spinal stenosis.

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          Most cited references 9

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          Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study.

          A prospective observational cohort study. To assess long-term outcomes of patients with lumbar spinal stenosis treated surgically or nonsurgically. The relative benefit of various treatments for lumbar spinal stenosis is uncertain. Surgical treatment has been associated with short-term improvement, but recurrence of symptoms has been documented. Few studies have compared long-term outcomes of surgical and nonsurgical treatments. Patients recruited from the practices of orthopaedic surgeons, neurosurgeons, and occupational medicine physicians throughout Maine had baseline interviews with follow-up questionnaires mailed at regular intervals over 10 years. Clinical data were obtained at baseline from a physician questionnaire. Most patients initially undergoing surgery had a laminectomy without fusion performed. Outcomes including patient-reported symptoms of leg and back pain, functional status, and satisfaction were assessed at 8- to 10-year follow-up. Primary analyses were based on initial treatment received with secondary analyses examining actual treatment received by 10 years. Of 148 eligible consenting patients initially enrolled, 105 were alive after 10 years (67.7% survival rate). Among surviving patients, long-term follow-up between 8 and 10 years was available for 97 of 123 (79%) patients (including 11 patients who died before the 10-year follow-up but completed a 8 or 9 year survey); 56 of 63 (89%) initially treated surgically and 41 of 60 (68%) initially treated nonsurgically. Patients undergoing surgery had worse baseline symptoms and functional status than those initially treated nonsurgically. Outcomes at 1 and 4 years favored initial surgical treatment. After 8 to 10 years, a similar percentage of surgical and nonsurgical patients reported that their low back pain was improved(53% vs. 50%, P = 0.8), their predominant symptom (either back or leg pain) was improved (54% vs. 42%, P = 0.3), and they were satisfied with their current status (55% vs. 49%, P = 0.5). These treatment group findings persisted after adjustment for other determinants of outcome in multivariate models. However, patients initially treated surgically reported less severe leg pain symptoms and greater improvement in back-specific functional status after 8 to 10 years than nonsurgically treated patients. By 10 years, 23% of surgical patients had undergone at least one additional lumbar spine operation, and 39% of nonsurgical patients had at least one lumbar spine operation. Patients undergoing subsequent surgical procedures had worse outcomes than those continuing with their initial treatment. Outcomes according to actual treatment received at 10 years did not differ because individuals undergoing additional surgical procedures had worse outcomes than those continuing with their initial treatment. Among patients with lumbar spinal stenosis completing 8- to 10-year follow-up, low back pain relief, predominant symptom improvement, and satisfaction with the current state were similar in patients initially treated surgically or nonsurgically. However, leg pain relief and greater back-related functional status continued to favor those initially receiving surgical treatment. These results support a shared decision-making approach among physicians and patients when considering treatment options for lumbar spinal stenosis.
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            Clinical practice. Lumbar spinal stenosis.

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              An assessment of surgery for spinal stenosis: time trends, geographic variations, complications, and reoperations.

               S Kreif,  M Ciol,  R Deyo (1996)
              To study temporal trends and geographic variations in the use of surgery for spinal stenosis, estimate short-term morbidity and mortality of the procedure, and examine the likelihood of repeat back surgery after surgical repair. Cohort study based on Medicare claims. Hospital care. All Medicare beneficiaries 65 years of age or older who received a lumbar spine operation for spinal stenosis in 1985 or 1989 were followed through 1991 (10,260 patients from the 1985 cohort and 18,655 from the 1989 cohort). Two outcomes were measured: (1) rates of operation for spinal stenosis by state and (2) on an individual level, operative complications (cardiopulmonary, vascular, or infectious), postoperative mortality, and time between first operation and any subsequent reoperation. Rates of surgery for spinal stenosis increased eightfold from 1979 to 1992 for patients aged 65 and older and varied almost fivefold among US states. Mortality and operative complications increased with age and comorbidity. Complications were more likely for men and for individuals receiving spinal fusions. The 1989 cohort experienced a slightly higher probability of reoperation than the 1985 cohort for the first 3 years of follow-up. A rapid increase in surgery rates for spinal stenosis was identified over a 14-year period. The wide geographic variations and substantial complication rate from this elective surgical procedure (partly related to patient age) suggest a need for more information on the relative efficacy of surgical and nonsurgical treatments for this condition. The risks and benefits of particular surgical procedures for specific clinical and demographic subgroups as well as individual patient preferences regarding surgical risks and possible outcomes should also be evaluated further. These issues are likely to become increasingly important with the aging of the US population.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2015
                03 October 2015
                : 8
                : 657-662
                Affiliations
                [1 ]The Spine Center, University of Colorado Hospital, Denver, CO, USA
                [2 ]Spine Institute of Louisiana, Shreveport, LA, USA
                [3 ]Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, New Haven, CT, USA
                [4 ]Performance Spine and Sports Physicians, PC, Pottstown, PA, USA
                [5 ]Texas Back Institute, Denton, TX, USA
                [6 ]Department of Neurological Surgery, Stony Brook Medicine, Stony Brook, NY, USA
                [7 ]Jon Block, Ph.D. San Francisco, CA, USA
                [8 ]McLaren Hospital, Petoskey, MI, USA
                Author notes
                Correspondence: Jon E Block, Jon Block, Ph.D. 2210 Jackson Street, Suite 401, San Francisco, CA 94115, USA, Tel +1 415 775 7947, Email jb@ 123456drjonblock.com
                Article
                jpr-8-657
                10.2147/JPR.S92633
                4599047
                © 2015 Patel et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Original Research

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