Trial reportWorld neurosurgery2017
Superion Interspinous Spacer Treatment of Moderate Spinal Stenosis: 4-Year Results.
Trial report in World neurosurgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed.
- 24-Month Outcomes of Indirect Decompression Using a Minimally Invasive Interspinous Fixation Device versus Standard Open Direct Decompression for Lumbar Spinal Stenosis: A Prospective Comparison.Journal of pain research · 2024Trial
- Five-year outcomes from a multi-center prospective randomized controlled trial of minimally invasive interspinous fixation versus open direct decompression for lumbar spinal stenosis.Interventional pain medicine · 2026Article
- Efficacy and Safety of the Use of Interspinous Spacers in the Treatment of Lumbar Spinal Stenosis: Mapping Gap and Scoping Review.Pain practice : the official journal of World Institute of Pain · 2026Article
- Standalone interspinous process devices for lumbar spinal stenosis: a critical literature review.BMC surgery · 2026Review
- Comparison analysis of safety outcomes and the rate of subsequent spinal procedures between interspinous spacer without decompression versus minimally invasive lumbar decompression.Regional anesthesia and pain medicine · 2024Article
- Longitudinal Analysis of the Care Pathway of Patients with Lumbar Spinal Stenosis in the US.Journal of pain research · 2024Article
- Longitudinal Comparative Analysis of Complications and Subsequent Interventions Following Stand-Alone Interspinous Spacers, Open Decompression, or Fusion for Lumbar Stenosis.Advances in therapy · 2023Article
- Instrumented Posterior Arthrodesis of the Lumbar Spine: Prospective Study Evaluating Fusion Outcomes in Patients Receiving an Interspinous Fixation Device for the Treatment of Degenerative Spine Diseases.Journal of pain research · 2023Article
- 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.International journal of spine surgery · 2022Article
- Neurosurgical Management of Interspinous Device Complications: A Case Series.Frontiers in surgery · 2022Article
- Decompression Using Minimally Invasive Surgery for Lumbar Spinal Stenosis Associated with Degenerative Spondylolisthesis: A Review.Pain and therapy · 2021Review
- Comparison of Adverse Outcomes Following Placement of Superion Interspinous Spacer Device Versus Laminectomy and Laminotomy.International journal of spine surgery · 2021Article
- Decompression Surgery versus Interspinous Devices for Lumbar Spinal Stenosis: A Systematic Review of the Literature.Asian spine journal · 2020Article
- An Algorithmic Approach to Treating Lumbar Spinal Stenosis: An Evidenced-Based Approach.Pain medicine (Malden, Mass.) · 2019Review
- A Review of Lumbar Spinal Stenosis with Intermittent Neurogenic Claudication: Disease and Diagnosis.Pain medicine (Malden, Mass.) · 2019Review
- Editorial on: "SuperionJournal of spine surgery (Hong Kong) · 2018Article
- Interspinous Process Decompression Improves Quality of Life in Patients with Lumbar Spinal Stenosis.Minimally invasive surgery · 2018Article
- Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis.Journal of pain research · 2018Article
- Idio Scale Judgment: evaluation of a new method for estimating responder thresholds.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2017Article
Corrections and comments
- Commented on by
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine 4-year clinical outcomes in patients with moderate lumbar spinal stenosis treated with minimally invasive stand-alone interspinous process decompression using the Superion device.
methodsThe 4-year Superion data were extracted from a randomized, controlled Food and Drug Administration investigational device exemption trial. Patients with intermittent neurogenic claudication relieved with back flexion who failed at least 6 months of nonsurgical management were enrolled. Outcomes included Zurich Claudication Questionnaire (ZCQ) symptom severity (ss), physical function (pf) and patient satisfaction (ps) subdomains, leg and back pain visual analog scale (VAS), and Oswestry Disability Index (ODI). At 4-year follow-up, 89 of the 122 patients (73%) provided complete clinical outcome evaluations.
resultsAt 4 years after index procedure, 75 of 89 patients with Superion (84.3%) demonstrated clinical success on at least 2 of 3 ZCQ domains. Individual component responder rates were 83% (74/89), 79% (70/89), and 87% (77/89) for ZCQss, ZCQpf, and ZCQps; 78% (67/86) and 66% (57/86) for leg and back pain VAS; and 62% (55/89) for ODI. Patients with Superion also demonstrated percentage improvements over baseline of 41%, 40%, 73%, 69%, and 61% for ZCQss, ZCQpf, leg pain VAS, back pain VAS, and ODI. Within-group effect sizes all were classified as very large (>1.0): 1.49, 1.65, 1.42, 1.12, and 1.46 for ZCQss, ZCQpf, leg pain VAS, back pain VAS, and ODI.
conclusionsMinimally invasive implantation of the Superion device provides long-term, durable relief of symptoms of intermittent neurogenic claudication for patients with moderate lumbar spinal stenosis.
Indexed as
Identifiers
28479526What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.