Stand-alone interspinous spacer versus decompressive laminectomy for treatment of lumbar spinal stenosis

Lauryssen, Carl; Jackson, Robert J.; Baron, Jeffrey; Tallarico, Richard A.; Lavelle, William F.; Deutsch, Harel; Block, Jon E.; Geisler, Fred H.

doi:10.1586/17434440.2015.1100071

Cited by 24 publications

(15 citation statements)

References 25 publications

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“…Lauryssen et al [17] documented consistently similar clinical improvements in back and leg pain, back function, and condition-specific impairment for both the Superion and decompressive laminectomy at 2 years postoperatively. Herein, we found robust effect sizes (>1.0) at each postoperative follow-up interval for ODI and ZCQ with Superion treatment, uniformly higher than comparable effect sizes with laminectomy, and the magnitude of the effect size was durable through 4 years of follow-up.…”

Section: Discussionmentioning

confidence: 96%

Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis

Nunley

Shamie

Blumenthal

et al. 2016

BioMed Research International

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Interspinous process decompression is a minimally invasive implantation procedure employing a stand-alone interspinous spacer that functions as an extension blocker to prevent compression of neural elements without direct surgical removal of tissue adjacent to the nerves. The Superion® spacer is the only FDA approved stand-alone device available in the US. It is also the only spacer approved by the CMS to be implanted in an ambulatory surgery center. We computed the within-group effect sizes from the Superion IDE trial and compared them to results extrapolated from two randomized trials of decompressive laminectomy. For the ODI, effect sizes were all very large (>1.0) for Superion and laminectomy at 2, 3, and 4 years. For ZCQ, the 2-year Superion symptom severity (1.26) and physical function (1.29) domains were very large; laminectomy effect sizes were very large (1.07) for symptom severity and large for physical function (0.80). Current projections indicate a marked increase in the number of patients with spinal stenosis. Consequently, there remains a keen interest in minimally invasive treatment options that delay or obviate the need for invasive surgical procedures, such as decompressive laminectomy or fusion. Stand-alone interspinous spacers may fill a currently unmet treatment gap in the continuum of care and help to reduce the burden of this chronic degenerative condition on the health care system.

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Section: Discussionmentioning

confidence: 96%

Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis

Nunley

Shamie

Blumenthal

et al. 2016

BioMed Research International

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“…Compared to the X-STOP spacer with large surgical exposure, the minimally invasive nature of the Superion spacer contributes to smaller blood loss, less operative time, and shorter hospitalization. In addition to its small incision, the Superion procedure avoids generating large scar tissue around symptomatic levels which may reduce the intricacy of future revision, removal, or further decompression surgery [ 24 ]. The data from previous 2-year follow-up studies suggested that both DI and the Superion procedure provide effective and durable symptom relief of claudication symptom.…”

Section: Discussionmentioning

confidence: 99%

RETRACTED ARTICLE: Comparison of two FDA-approved interspinous spacers for treatment of lumbar spinal stenosis: Superion versus X-STOP—a meta-analysis from five randomized controlled trial studies

Zhao

Duan²,

Gao

et al. 2018

J Orthop Surg Res

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BackgroundDecompressive laminectomy (DI) is a standard operation for lumbar spinal stenosis (LSS) patient with severe claudication symptoms for many years. However, patients whose symptom severity does not meet undergoing invasive surgery make therapeutic options into dilemma. Interspinous spacers (ISP) bridge the gap between surgical interventions and CC in management of LSS. In our study, we aim to systematically assess the two FDA-approved interspinous spacers for treatment of lumbar spinal stenosis: Superion versus X-STOP.MethodsElectronic databases, including PubMed, Embase, MEDLINE, Cochrane Library were searched to retrieve clinical trials concerning the comparison between Superion and X-STOP in treatment for lumbar spinal stenosis before April 2017. The following outcome measures were extracted: (1) Zurich Claudication Questionnaire (ZCQ) patient satisfaction score, (2) axial pain severity, (3) extremity pain severity, (4) back-specific functional impairment, (5) reoperation, and (6) complication. The data analysis was conducted with Review Manager 5.3.ResultsFive randomized controlled trials (RCTs) with 1118 patients were included in this meta-analysis. The pooled analysis indicated that the Superion group is superior to X-STOP in axial pain severity (SMD: 0.03; 95% CI 0.15, 0.45; p < 0.0001, I2 = 41%, p = 0.16), ZCQ patient satisfaction score (SMD: 0.23; 95% CI 0.08, 0.38; p = 0.002, I2 = 0%, p = 0.61). However, Superion group showed similarity outcome in extremity pain severity (SMD: 0.18; 95% CI − 0.06, 0.43; p = 0.14, I2 = 62%, p = 0.05), back-specific functional impairment (SMD: 0.04; 95% CI − 0.10, 0.19; p = 0.56, I2 = 0%, p = 0.77), reoperation rate (RR: 1.10; 95% CI 0.82, 1.48; p = 0.51, I2 = 19%, p = 0.30), and complication (RR: 0.98; 95% CI 0.63, 1.53; p = 0.92, I2 = 0%, p = 0.83).ConclusionBoth the Superion and X-STOP interspinous spacers can relieve symptoms of LSS. In addition, the Superion spacer may represent a promising spacer for patient with LSS. As we know, the effectiveness and safety of ISP is still considered investigational and unfavor clinical results in the medical literature may continue to limit the appeal of IPS to many surgeons in the future. However, because of the advantage of IPS technique, it will win a wide place in the future degenerative lumbar microsurgery.

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“…Lauryssen et al published a review article in 2015 comparing the results of the IDE trial to a compilation of 19 published studies on the use of decompressive laminectomy for the treatment of LSS. 88 The article compared back and leg pain, ODI score, and ZCQ score between those in the IDE study treated with ISS and the published results for patients treated with laminectomy. The percentage improvements at 24 months uniformly favored those treated with ISS compared to baseline scores.…”

Section: Interspinous Spacers For Indirect Lumbar Decompressionmentioning

confidence: 99%

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment

Deer¹,

Grider

Pope

et al. 2018

Pain Practice

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Background Lumbar spinal stenosis (LSS) can lead to compression of neural elements and manifest as low back and leg pain. LSS has traditionally been treated with a variety of conservative (pain medications, physical therapy, epidural spinal injections) and invasive (surgical decompression) options. Recently, several minimally invasive procedures have expanded the treatment options. Methods The Lumbar Spinal Stenosis Consensus Group convened to evaluate the peer‐reviewed literature as the basis for making minimally invasive spine treatment (MIST) recommendations. Eleven consensus points were clearly defined with evidence strength, recommendation grade, and consensus level using U.S. Preventive Services Task Force criteria. The Consensus Group also created a treatment algorithm. Literature searches yielded 9 studies (2 randomized controlled trials [RCTs]; 7 observational studies, 4 prospective and 3 retrospective) of minimally invasive spine treatments, and 1 RCT for spacers. Results The LSS treatment choice is dependent on the degree of stenosis; spinal or anatomic level; architecture of the stenosis; severity of the symptoms; failed, past, less invasive treatments; previous fusions or other open surgical approaches; and patient comorbidities. There is Level I evidence for percutaneous image‐guided lumbar decompression as superior to lumbar epidural steroid injection, and 1 RCT supported spacer use in a noninferiority study comparing 2 spacer products currently available. Conclusions MISTs should be used in a judicious and algorithmic fashion to treat LSS, based on the evidence of efficacy and safety in the peer‐reviewed literature. The MIST Consensus Group recommend that these procedures be used in a multimodal fashion as part of an evidence‐based decision algorithm.

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Stand-alone interspinous spacer versus decompressive laminectomy for treatment of lumbar spinal stenosis

Abstract: Both treatments provide effective and durable symptom relief of claudicant symptoms. This stand-alone interspinous spacer offers the patient a minimally invasive option with less surgical risk.

Cited by 24 publications

References 25 publications

Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis

Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis

RETRACTED ARTICLE: Comparison of two FDA-approved interspinous spacers for treatment of lumbar spinal stenosis: Superion versus X-STOP—a meta-analysis from five randomized controlled trial studies

The MIST Guidelines: The Lumbar Spinal Stenosis Consensus Group Guidelines for Minimally Invasive Spine Treatment

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