Cost-effectiveness of the X-STOP® Interspinous Spacer for Lumbar Spinal Stenosis

Skidmore, Grant; Ackerman, Stacey J.; Bergin, Christopher; Ross, Dan; Butler, Jesse P.; Suthar, Manish; Rittenberg, Joshua D.

doi:10.1097/brs.0b013e3181f2ed2f

Cited by 28 publications

(24 citation statements)

References 22 publications

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“…Similarly, Skidmore et al calculated the relative cost-effectiveness of the same three treatment strategies for LSS using clinical, quality of life, and economic data from various sources. 18 The authors demonstrated that in LSS patients with moderately impaired physical functioning, treatment with an interspinous spacer was cost-effective compared to conservative care (ICER = $17,894/QALY) and dominant to decompressive lumbar laminectomy (provided better improvement in quality of life and was less expensive).…”

Section: Discussionmentioning

confidence: 99%

“…5,[9][10][11][12][13] However, open lumbar laminectomy has been shown to be associated with post-operative complication rates ranging from 12 to 29%, depending on comorbidity status, which is particularly important since LSS is predominantly a disease of the elderly, a demographic inherently associated with higher rates of comorbidities. [14][15][16][17][18] As a result, less invasive surgical treatment strategies have been explored to manage patients with LSS refractory to conservative care. One such alternative is an interspinous device, which can be implanted between the spinous processes in the lumbar spine.…”

Section: Introductionmentioning

confidence: 99%

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Cost-effectiveness of three treatment strategies for lumbar spinal stenosis: Conservative care, laminectomy, and the Superion interspinous spacer

et al. 2015

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BackgroundLumbar spinal stenosis is a painful and debilitating condition resulting in healthcare costs totaling tens of billions of dollars annually. Initial treatment consists of conservative care modalities such as physical therapy, NSAIDs, opioids, and steroid injections. Patients refractory to these therapies can undergo decompressive surgery, which has good long-term efficacy but is more traumatic and can be associated with high post-operative adverse event (AE) rates. Interspinous spacers have been developed to offer a less-invasive alternative. The objective of this study was to compare the costs and quality adjusted life years (QALYs) gained of conservative care (CC) and decompressive surgery (DS) to a new minimally-invasive interspinous spacer.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Cost-effectiveness of three treatment strategies for lumbar spinal stenosis: Conservative care, laminectomy, and the Superion interspinous spacer

et al. 2015

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“…These included a prospective randomized multi-center study (191 patients) [13], a study on preliminary experiences in ten patients only [14] and three in vitro studies [15][16][17]. Up to now a total of ten RCTs [13,[18][19][20][21][22][23][24][25] and three cost-effectiveness studies [26][27][28] were published.…”

Section: Case Studiesmentioning

confidence: 99%

“…Skidmore et al focused primarily on cost-effectiveness alongside a RCT (sponsored by Medtronic Inc.) comparing the X-Stop Ò with conservative care and laminectomy [27]. The authors used clinical outcomes, quality-of-life and economic data.…”

Section: Case Studiesmentioning

confidence: 99%

“…Regulatory processes are a key element in limiting these costs. It was striking that no data on cost-effectiveness for the Dynesys Ò were available, while only two studies with conflicting results were published for the X-Stop Ò [26,27]. From a cost-effectiveness point of view, these new devices might not have been approved.…”

Section: Challenges In Market Approval Processes Of Spinal Devicesmentioning

confidence: 99%

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Market approval processes for new types of spinal devices: challenges and recommendations for improvement

Bisschop

Tulder²

2016

Eur Spine J

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Background Spinal pathology and related symptoms are among the most common health problems and are associated with high health care costs and productivity losses. Due to the aging population, these costs are further increasing every year. Another important reason for the increasing costs is the market approval of new technologies, such as spinal devices that are usually more expensive than the existing technologies. Previous cases of medical device failure led to concern about possible deficiencies in the market approval process. Objective The objective is to provide an overview of U.S. Food and Drug Administration (FDA) regulation regarding spinal implants to delineate the challenges and opportunities that spine surgery currently faces. Methods In this paper, two cases of market entries of spinal devices are presented and evaluated to illustrate these deficiencies. Results Spinal implant regulation is facing several challenges. New spinal devices should increase patient outcomes and safety at reasonable societal costs. The main challenge is to have a rigorous evaluation before dissemination, while still leaving room for innovative behavior that thrusts the healthcare practice forward. ConclusionWe have provided recommendations to enhance spinal implant regulation and improve and ensure the patient's safety and the future of spine surgery.

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Surgical options for lumbar spinal stenosis

Machado

Ferreira

Yoo

et al. 2016

Cochrane Database of Systematic Reviews

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The most common reason for spinal surgery in elderly patients is lumbar spinal stenosis (LSS). For LSS, treatment decisions based on clinical and radiological information as well as personal experience of the surgeon shows large variance. Thus a standardized support system is of high value for a more objective and reproducible decision. In this work, we develop an automated algorithm to localize the stenosis causing the symptoms of the patient in magnetic resonance imaging (MRI). With 22 MRI features of each of five spinal levels of 321 patients, we show it is possible to predict the location of lesion triggering the symptoms. To support this hypothesis, we conduct an automated analysis of labeled and unlabeled MRI scans extracted from 788 patients. We confirm quantitatively the importance of radiological information and provide an algorithmic pipeline for working with raw MRI scans.

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Cost-effectiveness of the X-STOP® Interspinous Spacer for Lumbar Spinal Stenosis

Cited by 28 publications

References 22 publications

Cost-effectiveness of three treatment strategies for lumbar spinal stenosis: Conservative care, laminectomy, and the Superion interspinous spacer

Cost-effectiveness of three treatment strategies for lumbar spinal stenosis: Conservative care, laminectomy, and the Superion interspinous spacer

Market approval processes for new types of spinal devices: challenges and recommendations for improvement

Surgical options for lumbar spinal stenosis

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