ArticleJournal of pain research2015
Superion(®) InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial.
Article in Journal of pain research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed.
- 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
- Pacific Spine and Pain Society (PSPS) Evidence Review of Surgical Treatments for Lumbar Degenerative Spinal Disease: A Narrative Review.Pain and therapy · 2024Review
- 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
- Current concepts of spondylosis and posterior spinal motion preservation for radiologists.Skeletal radiology · 2021Review
- An Algorithmic Approach to Treating Lumbar Spinal Stenosis: An Evidenced-Based Approach.Pain medicine (Malden, Mass.) · 2019Review
- Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis.Journal of pain research · 2018Article
- Interspinous Process Decompression Improves Quality of Life in Patients with Lumbar Spinal Stenosis.Minimally invasive surgery · 2018Article
- Interspinous implants: are the new implants better than the last generation? A review.Current reviews in musculoskeletal medicine · 2017Review
- Interspinous implants to treat spinal stenosis.Current reviews in musculoskeletal medicine · 2017Review
- Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis.Clinical interventions in aging · 2017Article
- Surgical and nonsurgical treatments for lumbar spinal stenosis.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2016Review
- Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis.BioMed research international · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis 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
methodsThe 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.
resultsAt 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.
conclusionThe 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.
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What 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.