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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

Overview
Publisher Biomed Central
Specialty Orthopedics
Date 2018 Mar 4
PMID 29499734
Citations 5
Authors
Affiliations
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Abstract

Background: Decompressive 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.

Methods: Electronic 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.

Results: Five 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, I = 41%, p = 0.16), ZCQ patient satisfaction score (SMD: 0.23; 95% CI 0.08, 0.38; p = 0.002, I = 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, I = 62%, p = 0.05), back-specific functional impairment (SMD: 0.04; 95% CI - 0.10, 0.19; p = 0.56, I = 0%, p = 0.77), reoperation rate (RR: 1.10; 95% CI 0.82, 1.48; p = 0.51, I = 19%, p = 0.30), and complication (RR: 0.98; 95% CI 0.63, 1.53; p = 0.92, I = 0%, p = 0.83).

Conclusion: Both 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.

Citing Articles

Biomechanical effect of Coflex and X-STOP spacers on the lumbar spine: a finite element analysis.

Guo Z, Liu G, Wang L, Zhao Y, Zhao Y, Lu S Am J Transl Res. 2022; 14(7):5155-5163.

PMID: 35958508 PMC: 9360861.


A Differential Clinical Benefit Examination of Full Lumbar Endoscopy vs Interspinous Process Spacers in the Treatment of Spinal Stenosis: An Effect Size Meta-Analysis of Clinical Outcomes.

Lewandrowski K, Abraham I, Leon J, Cantu-Leal R, Longoria R, Soriano Sanchez J Int J Spine Surg. 2022; 16(1):102-123.

PMID: 35177530 PMC: 9535687. DOI: 10.14444/8200.


Comparative efficacy and safety of surgical and invasive treatments for adults with degenerative lumbar spinal stenosis: protocol for a network meta-analysis and systematic review.

Chen L, Ferreira P, Beckenkamp P, Ferreira M BMJ Open. 2019; 9(4):e024752.

PMID: 30948574 PMC: 6500367. DOI: 10.1136/bmjopen-2018-024752.


Feasibility of Full Percutaneous Segmental Stabilization of the Lumbar Spine With a Combination of an Expandable Interbody Cage and an Interspinous Spacer: Preliminary Results.

Morgenstern R, Morgenstern C Int J Spine Surg. 2019; 12(6):665-672.

PMID: 30619669 PMC: 6314344. DOI: 10.14444/5083.


Retraction Note: 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 H, Duan L, Gao Y, Yang Y, Zhao D, Tang X J Orthop Surg Res. 2018; 13(1):138.

PMID: 29866198 PMC: 5987632. DOI: 10.1186/s13018-018-0845-7.

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