Evidence map›Paper›PMID 26769739›Full record

ArticleInterventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences2016

Degenerative lumbar spinal stenosis treatment with Aperius™ PerCLID™ system and Falena® interspinous spacers: 1-year follow-up of clinical outcome and quality of life.

Salvatore Masala, Stefano Marcia, Amedeo Taglieri, Antonio Chiaravalloti, Eros Calabria, Mario Raguso, Emanuele Piras, Giovanni Simonetti

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. 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 · 2020
    Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Salvatore MasalaDepartment of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
Stefano MarciaUOC Unitá Operativa Complessa Radiologia, Ospedale SS, Santissima Trinitá, Cagliari, Italy.
Amedeo TaglieriDepartment of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
Antonio ChiaravallotiDepartment of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
Eros CalabriaDepartment of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
Mario RagusoDepartment of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy marioraguso@hotmail.it.
Emanuele PirasUOC Unitá Operativa Complessa Radiologia, Ospedale SS, Santissima Trinitá, Cagliari, Italy.
Giovanni SimonettiDepartment of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
University of Rome Tor Vergata · ITSantissima Trinità · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeEvaluation of the efficacy of the Falena(®) and Aperius™ PerCLID™ interspinous devices in the treatment of degenerative lumbar spinal stenosis with neurogenic intermittent claudication refractory to conservative treatment. MATERIALS AND

methodsWe retrospectively analyzed data from 24 patients (20 male and 4 female patients; 61 ± 7 years old), treated with an implantation of the AperiusTM PerCLID™ system, and from 35 patients (29 male and 6 female patients; 65 ± 9 years old) treated with the Falena(®) interspinous device.Patient pain intensity was evaluated by a 10-point visual analog scale (VAS), with a score (ranging from 0 = no pain to 10 = unbearable pain) that was collected before the procedure, at baseline; and at months 1, 6 and 12 after the interventional procedure. The assessment of quality of life (QOL) impairment was evaluated by the Oswestry Disability Index (ODI) questionnaire, which was administered beforehand at baseline; and at months 1, 6 and 12 after the interventional procedure. The vertebral canal area was measured by magnetic resonance imaging (MRI) scans before the treatment and at the one-year follow-up.

resultsAll patients completed the study with no complications. Both the Falena group and Aperius group of surgery patients showed a statistically significant reduction of their VAS and ODI scores at the 6- and 12-month follow-up (p < 0.0001). A statistically significant increase in the vertebral canal area was observed both in the group that received Falena (p < 0.0001) and in the group that received Aperius (p = 0.0003). At the 1-year follow-up, we observed that there was a higher increase of vertebral canal area in those patients whom were treated with the Falena device (p < 0.001).

conclusionsThe implantation of Falena(®) and Aperius™ PerCLID™ interspinous devices is an effective and safe procedure, in the medium term.

Indexed as

Internal FixatorsAgedFemaleFollow-Up StudiesHumansIntermittent ClaudicationIntervertebral Disc DegenerationLumbosacral RegionMagnetic Resonance ImagingMaleMiddle AgedMinimally Invasive Surgical ProceduresPain MeasurementProsthesis ImplantationQuality of LifeRetrospective StudiesDegenerative diseaseinterspinous devicesinterspinous spacerslumbar spinal stenosismedical devicesneurogenic intermittent claudicationpercutaneous interspinous devicespinal surgeryvertebral canal

Identifiers

PMID26769739
PMCPMC4984346
OpenAlexW2285656327

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.