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

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.

SUBMITTER: Patel VV

PROVIDER: S-EPMC4599047 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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

Patel Vikas V VV Nunley Pierce D PD Whang Peter G PG Haley Thomas R TR Bradley W Daniel WD Davis Raphael P RP Block Jon E JE Geisler Fred H FH

Journal of pain research 20151003

<h4>Purpose</h4>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.<h4>Patients and methods</h4>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 spi ...[more]

PMID: 26491369

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Project description:BACKGROUND:Degenerative lumbar spinal stenosis is a condition related to aging in which structural changes cause narrowing of the central canal and intervertebral foramen. It is currently the leading cause for spinal surgery in patients over 65 years. Interspinous process devices (IPDs) were introduced as a less invasive surgical alternative, but questions regarding safety, efficacy, and cost-effectiveness are still unanswered. OBJECTIVES:The aim of this study was to provide complete and reliable information regarding benefits and harms of IPDs when compared to conservative treatment or decompression surgery and suggest directions for forthcoming RCTs. METHODS:We searched MEDLINE, EMBASE, Cochrane Library, Scopus, and LILACS for randomized and quasi-randomized trials, without language or period restrictions, comparing IPDs to conservative treatment or decompressive surgery in adults with symptomatic degenerative lumbar spine stenosis. Data extraction and analysis were conducted following the Cochrane Handbook. Primary outcomes were pain assessment, functional impairment, Zurich Claudication Questionnaire, and reoperation rates. Secondary outcomes were quality of life, complications, and cost-effectiveness. This systematic review was registered at Prospero (International prospective register of systematic reviews) under number 42015023604. RESULTS:The search strategy resulted in 17 potentially eligible reports. At the end, nine reports were included and eight were excluded. Overall quality of evidence was low. One trial compared IPDs to conservative treatment: IPDs presented better pain, functional status, quality of life outcomes, and higher complication risk. Five trials compared IPDs to decompressive surgery: pain, functional status, and quality of life had similar outcomes. IPD implant presented a significantly higher risk of reoperation. We found low-quality evidence that IPDs resulted in similar outcomes when compared to standard decompression surgery. Primary and secondary outcomes were not measured in all studies and were often published in incomplete form. Subgroup analysis was not feasible. Difficulty in contacting authors may have prevented us of including data in quantitative analysis. CONCLUSIONS:Patients submitted to IPD implants had significantly higher rates of reoperation, with lower cost-effectiveness. Future trials should improve in design quality and data reporting, with longer follow-up periods.

Dataset Information

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

Publications

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

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