Trial reportBMC musculoskeletal disorders2014
Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis.
Trial report in BMC musculoskeletal disorders, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00692276 (A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer), which is not on this 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.
A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) System in Patients With Moderate Lumbar Spinal Stenosis
Who cites it
19 citing papers in PubMed, 29 citations in OpenAlex.
- 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
- The MOTION randomized controlled trial for treatment of lumbar spinal stenosis using the percutaneous mild® procedure: 5-year results.Interventional pain medicine · 2026Article
- Standalone interspinous process devices for lumbar spinal stenosis: a critical literature review.BMC surgery · 2026Review
- Lumbar Spinal Stenosis: Pathophysiology, Biomechanics, and Innovations in Diagnosis and Management.Journal of spine research and surgery · 2025Article
- 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
- 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
- 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
- Cost-effectiveness and Safety of Interspinous Process Decompression (Superion).Pain medicine (Malden, Mass.) · 2019Review
- The 2-Level Experience of Interlaminar Stabilization: 5-Year Follow-Up of a Prospective, Randomized Clinical Experience Compared to Fusion for the Sustainable Management of Spinal Stenosis.International journal of spine surgery · 2018Article
- Interspinous Process Decompression Improves Quality of Life in Patients with Lumbar Spinal Stenosis.Minimally invasive surgery · 2018Article
- Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis.Clinical interventions in aging · 2017Article
- Market approval processes for new types of spinal devices: challenges and recommendations for improvement.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2016Article
- Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial.International journal of spine surgery · 2016Article
- ISASS Recommendations/Coverage Criteria for Decompression with Interlaminar Stabilization - Coverage Indications, Limitations, and/or Medical Necessity.International journal of spine surgery · 2016Article
- Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis.BioMed research international · 2016Article
- Cost-effectiveness of three treatment strategies for lumbar spinal stenosis: Conservative care, laminectomy, and the Superion interspinous spacer.International journal of spine surgery · 2015Article
- Superion(®) InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial.Journal of pain research · 2015Article
- Grade 1 spondylolisthesis and interspinous device placement: removal in six patients and analysis of current data.Surgical neurology international · 2015Article
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 at 4 institutions in 1 country.
Funding
Abstract
backgroundInterspinous spacers are a minimally invasive surgical alternative for patients with lumbar spinal stenosis (LSS) unresponsive to conservative care. The purpose of this prospective, multicenter, randomized, controlled trial was to compare 2-year clinical outcomes in patients with moderate LSS treated with the Superion(®) (Experimental) or the X-Stop(®), a FDA-approved interspinous spacer (Control).
methodsA total of 250 patients with moderate LSS unresponsive to conservative care were randomly allocated to treatment with the Experimental (n = 123) or Control (n = 127) interspinous spacer and followed through 2 years post-treatment. Complication data were available for all patients and patient-reported outcomes were available for 192 patients (101 Experimental, 91 Control) at 2 years.
resultsZurich Claudication Questionnaire (ZCQ) Symptom Severity and Physical Function scores improved 34% to 36% in both groups through 2 years (all p < 0.001). Patient Satisfaction scores at 2 years were 1.8 ± 0.9 with Experimental and 1.6 ± 0.8 with Control. Axial pain decreased from 59 ± 26 mm at baseline to 21 ± 26 mm at 2 years with Experimental and from 55 ± 26 mm to 21 ± 25 mm with Control (both p < 0.001). Extremity pain decreased from 67 ± 24 mm to 14 ± 22 mm at 2 years with Experimental and from 63 ± 24 mm to 18 ± 23 mm with Control (both p < 0.001). Back function assessed with the Oswestry Disability Index similarly improved with Experimental (37 ± 12% to 18 ± 16%) and Control (39 ± 12% to 20 ± 16%) (both p < 0.001). Freedom from reoperation at the index level was 84% for Experimental and 83% for Control (log-rank: p = 0.38) at 2 years.
conclusionsBoth interspinous spacers effectively alleviated pain and improved back function to a similar degree through 2 years in patients with moderate LSS who were unresponsive to conservative care.
trial registrationNCT00692276.
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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.