Trial reportBMJ (Clinical research ed.)2013
Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial.
Trial report in BMJ (Clinical research ed.), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 7 of them syntheses that pooled it.
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
38 citing papers in PubMed, 7 syntheses or guidelines pooled it, 97 citations in OpenAlex.
- Surgical interventions for degenerative lumbar spinal stenosis: a systematic review with network meta-analysis.BMC medicine · 2024Pooled it
- Clinical Evaluation of Surgery for Single-Segment Lumbar Spinal Stenosis: A Systematic Review and Bayesian Network Meta-Analysis.Orthopaedic surgery · 2022Pooled it
- Interspinous process devices for the treatment of neurogenic intermittent claudication: a systematic review of randomized controlled trials.Neurosurgical review · 2017Pooled it
- Surgical options for lumbar spinal stenosis.The Cochrane database of systematic reviews · 2016Pooled it
- Management of lumbar spinal stenosis.BMJ (Clinical research ed.) · 2016Pooled it
- Effectiveness of surgery for lumbar spinal stenosis: a systematic review and meta-analysis.PloS one · 2015Pooled it
- Interspinous spacer versus traditional decompressive surgery for lumbar spinal stenosis: a systematic review and meta-analysis.PloS one · 2014Pooled it
- 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
- Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?Neurosurgery · 2018Trial
- IPD without bony decompression versus conventional surgical decompression for lumbar spinal stenosis: 2-year results of a double-blind randomized controlled trial.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 · 2015Trial
- Preoperative Computed Tomography-Based Prediction of Device Size for Lumbar Stabilization with Interspinous Process Device for Lumbar Spinal Canal Stenosis.Spine surgery and related research · 2026Article
- 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
- The renewed role of interspinous devices: the InSpan system-a narrative review on surgical indications.Journal of spine surgery (Hong Kong) · 2026Review
- Computational analysis of L4-L5 interspinous process devices and interbody fusion spacers using ceramic and polymeric materials via finite element modeling and artificial intelligence.Scientific reports · 2025Article
- Lumbar Stabilization with Interspinous Process Devices for Lumbar Spinal Canal Stenosis.Neurologia medico-chirurgica · 2025Article
- Validity of outcome measures used in randomized clinical trials and observational studies in degenerative lumbar spinal stenosis.Scientific reports · 2023Article
- Biomechanical comparison of different interspinous process devices in the treatment of lumbar spinal stenosis: a finite element analysis.BMC musculoskeletal disorders · 2022Article
- Article
- The use of minimally invasive interspinous process devices for the treatment of lumbar canal stenosis: a narrative literature review.Journal of spine surgery (Hong Kong) · 2021Review
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis.
designRandomized controlled trial.
settingFive neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands.
participants203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized.
interventions80 participants received an interspinous process device and 79 participants underwent spinal bony decompression.
main outcome measuresThe primary outcome at short term (eight weeks) and long term (one year) follow-up was the Zurich Claudication Questionnaire score. Repeated measurements were made to compare outcomes over time.
resultsAt eight weeks, the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for standard bony decompression (72%, 60% to 81%). No differences in disability (Zurich Claudication Questionnaire; P=0.44) or other outcomes were observed between groups during the first year. The repeat surgery rate in the interspinous implant group was substantially higher (n=21; 29%) than that in the conventional group (n=6; 8%) in the early post-surgical period (P<0.001).
conclusionsThis double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional "simple" decompression and even showed a fairly high reoperation rate after interspinous process device implantation.
trial registrationDutch Trial Register NTR1307.
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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.