Trial reportNeurosurgery2018
Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication: An Alternative in Selected Patients?
Trial report in Neurosurgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 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
18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- Surgical interventions for degenerative lumbar spinal stenosis: a systematic review with network meta-analysis.BMC medicine · 2024Pooled it
- Is the interspinous process device safe and effective in elderly patients with lumbar degeneration? A systematic review and meta-analysis of randomized controlled trials.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 · 2024Pooled it
- Clinical Evaluation of Surgery for Single-Segment Lumbar Spinal Stenosis: A Systematic Review and Bayesian Network Meta-Analysis.Orthopaedic surgery · 2022Pooled it
- 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
- Percutaneous removal and replacement of a novel percutaneous interspinous device.The neuroradiology journal · 2024Article
- Effectiveness of Interspinous Process Devices in Managing Adjacent Segment Degeneration Following Lumbar Spinal Fusion: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2024Review
- Pacific Spine and Pain Society (PSPS) Evidence Review of Surgical Treatments for Lumbar Degenerative Spinal Disease: A Narrative Review.Pain and therapy · 2024Review
- Biomechanical Evaluation of Transforaminal Lumbar Interbody Fusion with Coflex-F and Pedicle Screw Fixation: Finite Element Analysis of Static and Vibration Conditions.Orthopaedic surgery · 2022Article
- Clinical and radiological outcomes following insertion of a novel removable percutaneous interspinous process spacer: an initial experience.Neuroradiology · 2022Observational
- 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
- 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
- Which is the most effective treatment for lumbar spinal stenosis: Decompression, fusion, or interspinous process device? A Bayesian network meta-analysis.Journal of orthopaedic translation · 2021Article
- Mobility-Preserving Surgery for Lumbar Spinal Stenosis: WFNS Spine Committee Recommendations.World neurosurgery: X · 2020Article
- Superiority Claims for Spinal Devices: A Systematic Review of Randomized Controlled Trials.Global spine journal · 2020Article
- Axial loading during MRI reveals insufficient effect of percutaneous interspinous implants (Aperius™ PerCLID™) on spinal canal area.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 · 2020Article
- [The importance of interspinous spacers in the treatment of lumbar spinal stenosis].Der Orthopade · 2019Review
- Percutaneous Interspinous Spacer in Spinal-Canal-Stenosis Treatment: Pros and Cons.Medicina (Kaunas, Lithuania) · 2019Review
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 2 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundStandalone interspinous process devices (IPDs) to treat degenerative lumbar spinal stenosis with neurogenic intermittent claudication (NIC) have shown ambiguous results in the literature.
objectiveTo show that a minimally invasive percutaneous IPD is safe and noninferior to standalone decompressive surgery (SDS) for patients with degenerative lumbar spinal stenosis with NIC.
methodsA multicenter, international, randomized, controlled trial (RCT) was con- ducted. One hundred sixty-three patients, enrolled at 19 sites, were randomized 1:1 to treatment with IPD or SDS and were followed for 24 mo.
resultsThere was significant improvement in Zurich Claudication Questionnaire physical function, as mean percentage change from baseline, for both the IPD and the SDS groups at 12 mo (primary endpoint) and 24 mo (-32.3 ± 32.1, -37.5 ± 22.8; and -37.9 ± 21.7%, -35.2 ± 22.8, both P < .001). IPD treatment was not significantly noninferior (margin: 10%) to SDS treatment at 12 mo (P = .172) but was significantly noninferior at 24 mo (P = .005). Symptom severity, patient satisfaction, visual analog scale leg pain, and SF-36 improved in both groups over time. IPD showed lower mean surgical time and mean blood loss (24 ± 11 min and 6 ± 11 mL) compared to SDS (70 ± 39 min and 189 ± 148 mL, both P < .001). Reoperations at index level occurred in 18.2% of the patients in the IPD group and in 9.3% in the SDS group.
conclusionConfirming 3 recent RCTs, we could show that IPD as well as open decompression achieve similar results in relieving symptoms of NIC in highly selected patients. However, despite some advantages in secondary outcomes, a higher reoperation rate for IPD is confirmed.
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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.